FDA Adverse Event
Injury
Summary report: N
PROSTAR XL SUTURE-MEDIATED CLOSURE
MDR report key: 1111535
·
Received August 13, 2008
Report
- Report Number
- 2953144-2008-01314
- Event Type
- Injury
- Date Received
- August 13, 2008
- Date of Event
- July 17, 2008
- Report Date
- July 23, 2008
- Manufacturer
- ABBOTT VASCULAR REDWOOD CITY
- Product Code
- MGB
- PMA / PMN Number
- P960043
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE.
Description of Event or Problem · 1
DEVICE MALFUNCTION: UNKNOWN. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, "THE DEVICE DID NOT WORK PROPERLY". THE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED USING A SECOND PROSTAR DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROSTAR XL SUTURE-MEDIATED CLOSURE | MGB | ABBOTT VASCULAR REDWOOD CITY | NA | 63178-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |