FDA Adverse Event
Malfunction
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 2973784
·
Received April 13, 2007
Report
- Report Number
- 2953144-2007-01336
- Event Type
- Malfunction
- Date Received
- April 13, 2007
- Date of Event
- March 8, 2007
- Report Date
- March 20, 2007
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- MGB
- Removal / Correction Number
- NA
- 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 INVESTIGATION. IT HAS NOT YET BEEN RECEIVED; HOWEVER, THE LOT NUMBER WAS REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT IS FORTHCOMING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THIS INFORMATION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE USING THE STARCLOSE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. THE CLIP FIRED AND DEPLOYED; HOWEVER, CLOSURE WAS NOT ACHIEVED. THE DEVICE COULD NOT BE REMOVED AND HAD TO BE PULLED OUT. MANUAL COMPRESSION WAS USED TO ACHIEVED CLOSURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE VASCULAR CLOSURE SYSTEM | VASCULAR CLOSURE SYSTEM | MGB | ABBOTT VASCULAR INC. | NA | 49119-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |