FDA Adverse Event
Other
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 959961
·
Received April 25, 2007
Report
- Report Number
- 2953144-2007-00544
- Event Type
- Other
- Date Received
- April 25, 2007
- Date of Event
- August 28, 2005
- Report Date
- September 28, 2005
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- MGB
- Removal / Correction Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
BASED ON AVAILABLE INFO, DEVICE MALFUNCTION COULD NOT BE IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS THAT ATTRIBUTED TO THIS INCIDENT. WE HAVE IDENTIFIED A COMPLAINT THAT HAS MET THE CRITERIA FOR REPORTABILITY. SUBSEQUENTLY, WE HAVE DETERMINED THAT THIS EVENT IS REPORTABLE AS AN ADVERSE EVENT.
Description of Event or Problem · 1
A PHYSICIAN ATTEMPTED AN ARTERIOTOMY CLOSURE USING THE STARCLOSE DEVICE. THE PHYSICIAN SUCCESSFULLY ACHIEVED CLOSURE, BUT THE END OF SHEATH SHEARED. THERE WAS NO FURTHER INFO AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE VASCULAR CLOSURE SYSTEM | VASCULAR CLOSURE SYSTEM | MGB | ABBOTT VASCULAR INC. | NA | 27085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |