FDA Adverse Event
Malfunction
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 2954088
·
Received April 23, 2007
Report
- Report Number
- 2953144-2007-00523
- Event Type
- Malfunction
- Date Received
- April 23, 2007
- Date of Event
- March 28, 2007
- Report Date
- March 28, 2007
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- MGB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT IS FORTHCOMING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH ANY RELEVANT INFO. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A TRAINED PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE USING THE STARCLOSE DEVICE AFTER AN UNKNOWN PROCEDURE. REPORTEDLY, THE VESSEL LOCATOR POPPED UP PREMATURELY. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THERE WERE NO PATIENT EFFECTS. NO ADD'L INFO 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 | 50011-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |