Note: Although this FDA-483 is an
accurate representation of the original FDA-483 issued to the firm, it is not an exact
copy. Slight modifications to the original FDA-483 have been made to accommodate its
conversion to the HTML format. A scanned copy of the original FDA-483 is available in PDF format on this website. |
DEPARTMENT
OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION |
DISTRICT
OFFICE ADDRESS AND PHONE NUMBER One
Montvale Avenue
Stoneham, MA 02180
(781) 596-7700 Fax:(781) 596-7896
|
DATE(S)
OF INSPECTION 07/27/2005 - 08/26/2005* |
FEI
NUMBER 3000204642 |
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Brian R. Burns, Senior Vice President, Global Quality Assurance |
FIRM
NAME
Boston Scientific Corporation |
STREET
ADDRESS
1 Boston Scientific Place |
CITY,
STATE AND ZIP CODE
Natick, MA 01760-1536 |
TYPE
OF ESTABLISHMENT INSPECTED
Manufacturer |
This document lists
observations made by the FDA representative(s) during the inspection
of your facility. They are inspectional observations, and do not
represent a final Agency determination regarding your compliance.
If you have an objection regarding an observation, or have implemented,
or plan to implement, corrective action in response to an observation,
you may discuss the objection or action with the FDA representative(s)
during the inspection or submit this information to FDA at the address
above. If you have any questions, please contact FDA at the phone
number and address above. |
The observations
noted in this Form FDA-483 are not an exhaustive listing of objectionable
conditions. Under the law, your firm is responsible for conducting
internal self-audits to identify and correct any and all violations
of the quality system requirements. |
DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:
Editorial note: Each page of this document included the
handwritten phrase “Not annotated” to indicate that
the firm’s comments during the presentation of the Form
FDA 483 are not included in this version.
OBSERVATION 1
Management with executive responsibility has not ensured that
an adequate and effective quality system has been fully implemented
and maintained at all levels of the organization.
Specifically,
-
Data trended monthly by Corporate for quarterly management
review meetings does not include all quality issues.
For example, complaints are trended monthly by rate and length
of time open. The late submissions of Medical Device Reports
(MDRs) is not included in the trending.
The Manager of Corporate Quality Systems Compliance said Corporate
trends metrics and timeliness. He said the details of
the Product Inquiry Reports (PIRs) are tracked by the sites.
-
Prior to June 2005,
trends were not required to be reported by product family. Now,
although they must be reported, if the site did not exceed their
pre-set goal for overall complaint rate for the month, the data
will be reported in green rather than red, so the reviewers may
not realize there is a trend listed.
-
The procedures for trending
state only that trending must be done, but do not explain specifically
what and how to trend data at the various BSC sites. For
example, review of the data trended by the Wayne, NJ facility
revealed discrepancies between their data and the comments included
on the complaint forms (which are reviewed at the Marlboro, MA
facility).
|
OBSERVATION 2
Employees who manage, perform, and assess work affecting quality
have not been provided the independence and authority to accomplish
their work.
[REDACTED 2 lines] |
OBSERVATION 3
A correction or removal, conducted to reduce a risk to health
posed by a device, was not reported in writing to FDA.
Specifically:
-
PIR # SJC-2005-01-01 initiated 12/3/2004: The firm's recall of the Position Acquisition Module (PAM)
as part of the RPM system (including 3 UPNs, all lots) was not
reported to FDA. The device is used on patients receiving ablation
for arrhythmias. The PAM does not meet IEC 60601-1 General
Requirements for Safety of Medical Electrical Equipment. During
overheating testing, it was discovered that the 70V secondary of
the PAM transformer failed short circuit testing, implying the
possibility of a fire hazard. The Clinical Assessment for
Severity is listed as Critical. The Field Action recommended
is to conduct a recall. The recall is classified by Boston
Scientific as Class III. This was approved by the FAC Chairperson
on 1/24/2005. The equipment has been distributed to both
US and OUS consignees.
-
PIR # SJC-2005-03-03 initiated 2/3/2005: The firm's recall of the Signal Acquisition Module (SAM3) as
part of the RPM system (including all UPNs starting with M004308300),
was not reported to FDA. The device is used on patients receiving
ablation for arrhythmias. The SAM3 does not meet IEC 60601-1
General Requirements for Safety of Medical Electrical Equipment. During
overheating testing, it was discovered that the secondary of the
SAM3 transformer failed short circuit testing, implying the possibility
of a fire hazard. The Clinical Assessment for Severity is
listed as Critical. The Field Action recommended is to conduct
a recall. The recall is classified by Boston Scientific as
Class III. This was approved by the FAC Chairperson on 3/14/2005. The
equipment has been distributed to both US and OUS consignees.
According to the Director of Corporate Quality Systems and Compliance,
all Product Inquiry Reports (PIRs) are signed by the Senior Vice
President of Global Quality Assurance, who is also the Field Action
Committee (FAC) Chairperson, who is located here at BSC-Natick. |
OBSERVATION 4
An MDR report was not submitted within 30 days of receiving or
otherwise becoming aware of information that reasonably suggests
that a marketed device may have caused or contributed to a death
or serious injury.
Specifically, Medical Device Reports (MDRs) were either not submitted
or were submitted late in the following instances:
- For Enteryx Procedure Kits:
- An MDR has not been submitted for complaint
# 655872 dated 4/13/05 involving: patient had dysphagia
with a subsequent dilatation.
- An MDR has not been submitted for complaint
# 655874 dated 4/13/05 involving: patient with dysphagia
and weight loss resulting in an EGD for which results have
not been reported.
- Complaint # 650765
dated 12/8/04 was reported on 1/17/05 (10 days late)
- Complaint # 657183
dated 5/2/05 was reported on 6/3/05 (2 days late)
- For Vaxcel Ports:
- Complaint # 640535 dated
3/17/04 was reported on 4/20/04 (4 days late)
- Complaint # 640726
dated 3/23/04 was reported on 4/23/04 (1 day late)
|
OBSERVATION 5
An MDR report was not submitted within 30 days of receiving or otherwise
becoming aware of information that reasonably suggests that a marketed
device has malfunctioned and would be likely to cause or contribute
to a death or serious injury if the malfunction were to recur.
Specifically, Medical Device Reports (MDRs) were either not submitted
or were submitted late in the following instances:
- For Vaxcel Dialysis Catheters:
- MDRs have not been submitted for complaint
# 647741 dated 9/16/04 involving: five units with cuff separation
and the catheter slipping out.
- An MDR has not been submitted for complaint
# 642926 dated 11/9/04 involving: a patient's catheter which
fell out at home.
- Complaint # 655187 dated
1/21/05 was reported on 4/4/05 (6 weeks late)
- Complaint # 655188 dated
1/21/05 was reported on 4/4/05 (6 weeks late)
- Complaint # 653673 dated 1/21/05 was
reported on 3/25/05 (4 ½ weeks late)
- Complaint # 651774 dated
1/5/05 was reported on 3/4/05 (4 weeks late)
- Complaint # 655350 dated
2/13/05 was reported on 4/8/05 (3+ weeks late)
- Complaint # 653670 dated
2/15/05 was reported on 3/25/05 (8 days late)
- Complaint # 653671 dated
2/16/05 was reported on 3/25/05 (1 week late)
- For Vaxcel Ports:
- An MDR has not been submitted for complaint
# 647625 dated 9/22/04 involving: Post placement could not flush
or draw; the port was removed and replaced the same day.
- Complaint # 639511 dated
2/20/04 was reported on 12/17/04 (9 months late)
- Complaint # 639513 dated
2/20/04 was reported on 12/17/04 (9 months late)
- Complaint # 639514 dated
2/20/04 was reported on 12/17/04 (9 months late)
- Complaint # 656751 dated
11/24/03 was reported on 4/23/04 (4 months late)
- Complaint # 646924 dated 9/3/04 was
reported on 1/27/05 (3 ½ months late)
- Complaint # 637445 dated
12/18/03 was reported on 4/8/04 (3+ months late)
- Complaint # 648812 dated
10/21/04 was reported on 1/14/05 (2 months late)
- Complaint # 648804 dated
10/21/04 was reported on 1/14/05 (2 months late)
- Complaint # 631548 dated
8/5/03 was reported on 10/30/03 (2 months late)
- Complaint # 640109 dated
3/3/04 was reported on 4/14/04 (12 days late)
- Complaint # 641509 dated
4/13/04 was reported on 5/18/04 (5 days late)
|
OBSERVATION 6
Complaints representing events that are MDR reportable were not promptly
reviewed, evaluated, and investigated by a designated individual.
Specifically, it is unclear who is making final MDR determinations.
- The Post Market Compliance
Specialist who reviews complaints for the Oncology product line
within the Endosurgery group for Medical Device Reportability, said
the Manager for Post Market Compliance for Endosurgery reviews all
of the complaints that are determined to be reportable, but not the
ones that are not reportable.
- The Senior Post Market Compliance
Specialist who reviews complaints for Endosurgery products said
that regardless of whether the complaints are reportable or not,
they are passed on to the Manager for Post Market Compliance for Endosurgery
and to a physician for the ultimate decision.
- The Manager for Post Market
Compliance for Endosurgery said she reviews every reportable complaint
for Endosurgery, but not complaints that are determined not to
be MDR reportable.
- The Manager for Post Market
Compliance for Endosurgery also said all Enteryx complaints go
to the Associate Medical Director, Endoscopy Division, Endosurgery
Clinical Affairs unless it is clearly not a clinical issue. This review
by the MD is not documented.
|
OBSERVATION 7
Complaint handling procedures have not been established to ensure that
all complaints are processed in a uniform and timely manner.
Specifically,
- There are inconsistent times from the date the
complaint was phoned in to the date it was entered into the computer
system. The Corporate SOP for Complaint Handling S841052-00
rev. AJ, states that "ALL employees shall forward
any BSC Product Concern to a Complaint Call Center within
72 hours or less of Becoming Aware of the concern".
- 651507
phoned in on 1/9/04, was entered on 12/29/04 (11 ½ months later)
- 655188
phoned in on 1/21/05, was entered on 3/29/05 (9 ½ weeks
later)
- 655187
phoned in on 1/21/05, was entered on 3/29/05 (9 ½ weeks
later)
- 654222 phoned in on 1/21/05, was entered on 3/8/05 (6 ½ weeks
later)
- 655350
phoned in on 2/13/05, was entered on 4/1/05 (6 ½ weeks
later)
- 653673
phoned in on 1/21/05, was entered on 2/23/05 (4 ½ weeks
later)
- 656542 phoned in on 3/31/05, was entered on 4/27/05 (4 weeks later)
- 656902
phoned in on 4/27/05, was entered on 5/6/05 (2+ weeks later)
- 657472 phoned in on 5/3/05, was entered on 5/18/05 (2+ weeks later)
- 657473
phoned in on 5/3/05, was entered on 5/18/05 (2+ weeks later)
- 656899
phoned in on 4/21/05, was entered on 5/6/05 (2+ weeks later)
- 656901
phoned in on 4/21/05, was entered on 5/6/05 (2 weeks later)
- 657183
phoned in on 5/2/05, was entered on 5/12/05 (10 days later)
- 653824
phoned in on 2/17/05, was entered on 2/26/05 (9 days later)
- 660560
phoned in on 7/15/05, was entered on 7/24/05 (9 days later)
- 655971
phoned in on 4/7/05, was entered on 4/15/05 (8 days later)
- 653670
phoned in on 2/15/05, was entered on 2/23/05 (8 days later)
- 656774
phoned in on 4/28/05, was entered on 5/4/05 (1 week later)
- 653671
phoned in on 2/16/05, was entered on 2/23/05 (1 week later)
- 655837
phoned in on 4/7/05, was entered on 4/13/05 (6 days later)
- 658261
phoned in on 6/2/05, was entered on 6/7/05 (5 days later)
- 654048
phoned in on 3/1/05, was entered on 3/3/05 (4 days later)
- The Date Reported (the date a BSC employee
learned of a complaint) has been listed incorrectly:
- 655653 has both a date reported and a phoned in date of 4/8/05,
however a comment in the complaint states that the findings were
reported to BSC on 3/30/05.
- 653671
has a phoned in date of 2/16/06, however a date reported of
2/23/05.
- There are inconsistencies in tracking open
vs. closed complaints, and tracking whether or not any information
is still outstanding.
- The Post Market Compliance
Specialist for the Oncology product line said the Principal
Post Market Compliance Specialist audits the closed complaints
by the close out date and that they may or may not still be under
investigation.
- The Post Market Compliance
Specialist for the Oncology product line also said she has
a manual process for following up on complaints: she keeps a folder with
copies of email messages regarding questions that are still pending
on complaints. She
said she does not look at the Investigation Closed Date and
does not know who enters that date.
- We observed numerous
complaints listing Investigation Closed Dates which were prior
to the Post Market Compliance Specialists receiving all information
regarding their investigation.
- The Post Market Compliance
Group at the Complaint Management Center (CMC) is responsible
for the MDR determination, according to the Corporate SOP for
MDR Reporting. The
close out of this investigation is not always documented in
the comments on the computer generated complaint form
|
* DATES OF INSPECTION
07/27/2005(Wed), 07/28/2005(Thu), 07/29/2005(Fri), 08/02/2005(Tue),
08/03/2005(Wed), 08/04/2005(Thu), 08/24/2005(Wed), 08/25/2005(Thu),
08/26/2005(Fri) |
FDA EMPLOYEE'S NAME, TITLE, AND SIGNATURE:
[Handwritten Signature]
Elizabeth B. Griffin, Engineer/Investigator
[Handwritten Signature]
Courtney N. Long, Investigator |
SEE
REVERSE
OF THIS
PAGE |
|
|
DATE
ISSUED 08/26/2005 |
FORM FDA 483 (7/00) PREVIOUS EDITION OBSOLETE
INSPECTIONAL OBSERVATIONS
Reverse Text on Page: The observations of objectional conditions and practices listed
on the front of this form are reported:
- Pursuant to Section 704(b) of the Federal Food, Drug and
Cosmetic Act, or
- To assist firms inspected in complying with the Acts and
regulations enforced by the Food and Drug Administration.
|
Section 704(b) of the Federal Food, Drug, and Cosmetic
Act (21 USC374(b)) provides: “Upon
completion of any such inspection of a factory, warehouse, consulting laboratory, or other
establishment, and prior to leaving the premises, the officer or employee making the
inspection shall give to the owner, operator, or agent in charge a report in writing
setting forth any conditions or practices observed by him which, in his judgement,
indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole
or in part of any filthy, putrid, or decomposed substance or (2) has been prepared,
packed, or held under insanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health. A copy of such report
shall be sent promptly to the Secretary.” |
Entries marked with this logo are PDF documents. You will need “Acrobat
Reader” to view it. If you do not have it installed on your computer, click on
the following link to download a free copy.
Back to Frequently Requested ORA Documents
and FDA 483s
|
|