FDA Adverse Event
Injury
Summary report: N
STARCLOSE SE VASCULAR CLOSURE SYSTEM
MDR report key: 1833201
·
Received September 9, 2010
Report
- Report Number
- 2953144-2010-01893
- Event Type
- Injury
- Date Received
- September 9, 2010
- Date of Event
- August 9, 2010
- Report Date
- August 19, 2010
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A NURSE IN-TRAINING IN THE USE OF THE STARCLOSE SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, NEAR COMPLETION OF THUMB ADVANCER DEPLOYMENT, THE CLIP PREMATURELY DEPLOYED IN SUBCUTANEOUS TISSUE. THE CLIP WAS REMOVED WITH FORCEPS AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE SE VASCULAR CLOSURE SYSTEM | MGB | ABBOTT VASCULAR - REDWOOD CITY | NA | 87051-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |