FDA Adverse Event
Injury
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 1002320
·
Received February 22, 2008
Report
- Report Number
- 2953144-2008-00092
- Event Type
- Injury
- Date Received
- February 22, 2008
- Date of Event
- January 17, 2008
- Report Date
- January 28, 2008
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- MGB
- PMA / PMN Number
- P050007
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem · 1
DEVICE MALFUNCTION: STUCK DEVICE. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT THE PHYSICIAN USED THE STARCLOSE DEVICE TO ATTEMPT ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. DIFFICULTY WAS ENCOUNTERED WHILE REMOVING THE DEVICE. AN INCISION WAS MADE TO GET THE DEVICE AND THE CLIP REMOVED FROM THE PT'S ANATOMY. THE INCISION WAS CLOSED AND HEMOSTASIS WAS ACHIEVED BY SUTURE. THERE WERE NO ADVERSE PT SEQUELAE. NO ADDITIONAL INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE VASCULAR CLOSURE SYSTEM | MGB | ABBOTT VASCULAR | NA | 56116-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |