FDA Adverse Event
Malfunction
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 1022124
·
Received March 25, 2008
Report
- Report Number
- 2953144-2008-00197
- Event Type
- Malfunction
- Date Received
- March 25, 2008
- Date of Event
- February 28, 2008
- Report Date
- February 29, 2008
- Manufacturer
- ABBOTT VASCULAR REDWOOD CITY
- Product Code
- MGB
- PMA / PMN Number
- P050007
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS IDENTIFIED, THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.
Description of Event or Problem · 1
DEVICE MALFUNCTION: CLIP DID NOT DEPLOY. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED FEMORAL ARTERIOTOMY CLOSURE AFTER AN UNSPECIFIED PROCEDURE. THE TRIGGER WAS DEPRESSED BUT THE CLIP DID NOT RELEASE. REPORTEDLY, ALL DEPLOYMENT STEPS WERE DONE CORRECTLY. HEMOSTASIS WAS ACHIEVED USING A FEMSTOP AND MANUAL COMPRESSION. THERE WAS NO ADVERSE PT SEQUELA. THOUGH REQUESTED, NO ADD'L 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 |