FDA Adverse Event
Injury
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 1241278
·
Received November 21, 2008
Report
- Report Number
- 2953144-2008-01899
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- October 27, 2008
- Report Date
- October 28, 2008
- Manufacturer
- ABBOTT VASCULAR - REDWOOD CITY
- Product Code
- MGB
- PMA / PMN Number
- P050007
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.
Description of Event or Problem · 1
DEVICE MALFUNCTION: UNKNOWN. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: VESSEL DISSECTION. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A VESSEL DISSECTION OCCURRED. IT WAS NOT KNOWN HOW THE DISSECTION OCCURRED OR HOW IT WAS TREATED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 |