FDA Adverse Event
Injury
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 1111541
·
Received August 13, 2008
Report
- Report Number
- 2953144-2008-01312
- Event Type
- Injury
- Date Received
- August 13, 2008
- Date of Event
- July 24, 2008
- Report Date
- July 24, 2008
- Manufacturer
- ABBOTT VASCULAR - REDWOOD CITY
- 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 EVALUATION. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.
Description of Event or Problem · 1
DEVICE MALFUNCTION: FAILURE TO DEPLOY VESSEL LOCATOR WINGS. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, "IT WASN'T POSSIBLE TO DEPLOY THE LOCATOR WINGS." THE DEVICE WAS REMOVED AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE VASCULAR CLOSURE SYSTEM | MGB | ABBOTT VASCULAR - REDWOOD CITY | NA | 65151-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |