FDA Adverse Event
Other
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 811365
·
Received January 24, 2007
Report
- Report Number
- 2953144-2007-00047
- Event Type
- Other
- Date Received
- January 24, 2007
- Date of Event
- November 4, 2006
- Report Date
- January 4, 2007
- Manufacturer
- ABBOTT VASCULAR, INC.
- Product Code
- FZP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED AND THERE WAS 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 SUCCESSFULLY CLOSED AN ARTERIOTOMY SITE WITH THE STARCLOSE DEVICE FOLLOWING AN UNK PROCEDURE IN 2006. THE PT RETURNED TO THE HOSP IN 2007, COMPLAINING OF PAIN IN THE GROIN. AN ANGIO REVEALED AN OCCLUSION AT THE PREVIOUS ACCESS SITE (COMMON FEMORAL ABOVE BIFURCATION). UNDER FLUORO, THE CLIP COULD BE SEEN AND THERE WAS NO OR SLOW CONTRAST FLOW AFTER THE CLIP SITE. A SURGICAL PROCEDURE IS PLANNED TO EITHER OPEN UP THE ARTERY OR REMOVE THE CLIP.
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 | YR | Other |