FDA Adverse Event
Injury
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 1190292
·
Received October 6, 2008
Report
- Report Number
- 2953144-2008-01627
- Event Type
- Injury
- Date Received
- October 6, 2008
- Date of Event
- September 3, 2008
- Report Date
- September 18, 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
- TN, US
- 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
SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. DEVICE MALFUNCTION: NONE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER UNEVENTFUL CLIP DEPLOYMENT BLEEDING CONTINUED. MANUAL COMPRESSION WAS APPLIED FOR TEN MINUTES TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE VASCULAR CLOSURE SYSTEM | MGB | ABBOTT VASCULAR - REDWOOD CITY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |