FDA Adverse Event
Other
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 959968
·
Received April 25, 2007
Report
- Report Number
- 2953144-2007-00546
- Event Type
- Other
- Date Received
- April 25, 2007
- Date of Event
- October 19, 2005
- Report Date
- October 19, 2005
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- MGB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A PHYSICIAN ATTEMPTED AN ARTERIOTOMY CLOSURE USING THE STARCLOSE DEVICE. THE SHAFT FROM THE DEVICE WAS BROKEN AND DURING THE SPLITTING OF SHEATH , THE PLASTIC SHAFT CAME OUT FROM THE SKIN INCISION. THE PHYSICIAN PRESSED THE SAFETY RELEASE BUTTON AND REMOVED THE DEVICE FROM THE PT. THE PHYSICIAN REVERTED TO MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS. REPORTEDLY, NO PART OF THE DEVICE REMAINED IN THE PT. THERE WAS NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE VASCULAR CLOSURE SYSTEM | VASCULAR CLOSURE SYSTEM | MGB | ABBOTT VASCULAR INC. | NA | 30099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |