FDA Adverse Event
Other
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 813282
·
Received January 12, 2007
Report
- Report Number
- 2953144-2007-00023
- Event Type
- Other
- Date Received
- January 12, 2007
- Date of Event
- March 10, 2006
- Report Date
- March 10, 2006
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- MGB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED DEVICE SHOWED A PUSHER BODY TO SHAFT NYLON JOINT BOND FAILURE. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INCIDENT. WE HAVE IDENTIFIED A MALFUNCTION THAT HAS MET THE CRITERIA FOR REPORTABILITY. SUBSEQUENTLY, WE HAVE DETERMINED THAT THIS EVENT IS REPORTABLE AS A "PRODUCT PROBLEM (MALFUNCTION)".
Description of Event or Problem · 1
A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE USING THE STARCLOSE DEVICE. THE PHYSICIAN FIRED THE CLIP AND TRIED TO REMOVE THE DEVICE. THE PHYSICIAN PULLED ON IT FORCEFULLY AND WAS ABLE TO WITHDRAW THE DEVICE. THE CLIP REMAINED IN THE PATIENT AND HEMOSTASIS WAS ACHIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE VASCULAR CLOSURE SYSTEM | VASCULAR CLOSURE SYSTEM | MGB | ABBOTT VASCULAR INC. | STARCLOSE VCS | 34121-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |