FDA Adverse Event
Injury
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 1002318
·
Received February 22, 2008
Report
- Report Number
- 2953144-2008-00093
- Event Type
- Injury
- Date Received
- February 22, 2008
- Date of Event
- January 29, 2008
- Report Date
- January 29, 2008
- Manufacturer
- ABBOTT VASCULAR - VASCULAR SOLUTIONS
- Product Code
- MGB
- PMA / PMN Number
- P050007
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
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
SYMPTOMS/AE: VESSEL OCCLUSION. TIME OF SYMPTOMS/AE: DURING THE PROCEDURE. IT WAS REPORTED THAT A PHYSICIAN ACHIEVED ARTERIOTOMY CLOSURE WITH THE STARCLOSE DEVICE, OF AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER THE CLIP WAS DEPLOYED IN THE VESSEL, THERE WAS AN OCCLUSION NOTED. A SURGICAL INTERVENTION IS PLANNED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE VASCULAR CLOSURE SYSTEM | MGB | ABBOTT VASCULAR - VASCULAR SOLUTIONS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |