FDA Adverse Event
Other
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 811370
·
Received January 11, 2007
Report
- Report Number
- 2953144-2007-00045
- Event Type
- Other
- Date Received
- January 11, 2007
- Date of Event
- December 29, 2006
- Report Date
- January 11, 2007
- Manufacturer
- ABBOTT VASCULAR, INC.
- Product Code
- FZP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED AND THERE WERE NO LOT INFO. WE WERE NOT ABLE TO PERFORM DEVICE INSPECTION OR DEVICE HISTORY RECORD REVIEW IN THIS CASE.
Description of Event or Problem · 1
THE PHYSICIAN ATTEMPTED CLOSURE OF AN ARTERIOTOMY SITE WITH THE STARCLOSE DEVICE FOLLOWING AN UNK PROCEDURE. THE DEVICE BECAME STUCK IN THE PT. THE PHYSICIAN PRESSED THE SAFETY RELEASE BUTTON, HOWEVER, THE DEVICE WOULD NOT RELEASE. COUNTER PRESSURE WAS APPLIED AND THE DEVICE WAS PULLED. WHEN THE DEVICE RELEASED, IT NICKED THE PHYSICIAN'S GLOVE AND FINGER. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE VASCULAR CLOSURE SYSTEM | VASCULAR CLOSURE SYSTEM | FZP | ABBOTT VASCULAR, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |