FDA Adverse Event
Injury
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 1032341
·
Received April 22, 2008
Report
- Report Number
- 2953144-2008-00775
- Event Type
- Injury
- Date Received
- April 22, 2008
- Date of Event
- March 31, 2008
- Report Date
- April 2, 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
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem · 1
DEVICE MALFUNCTION: FAILURE TO COMPLETE THUMB ADVANCER STEP. 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 STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE AFTER AN INTERVENTION PROCEDURE. REPORTEDLY, DURING STEP 3, RESISTANCE WAS FELT AND THE SHEATH DID NOT COMPLETELY SPLIT AND THE CLIP DID NOT DEPLOY. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION AND A FEMOSTOP. THERE WERE NO REPORTED ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.
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 |