FDA Adverse Event
Other
Summary report: N
STARCLOSE SE VASCULAR CLOSURE SYSTEM
MDR report key: 967386
·
Received November 5, 2007
Report
- Report Number
- 2953144-2007-00617
- Event Type
- Other
- Date Received
- November 5, 2007
- Date of Event
- March 7, 2007
- Report Date
- May 4, 2007
- Manufacturer
- ABBOTT VASCULAR INC
- Product Code
- MGB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 WITH A SCARCLOSE SE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. THE PHYSICIAN EXPERIENCED DIFFICULTY IN PULLING BACK THE DEVICE, AND A NEEDLE WAS USED TO REMOVE THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE SE VASCULAR CLOSURE SYSTEM | VASCULAR CLOSURE DEVICE | MGB | ABBOTT VASCULAR INC | NA | 46156-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Required Intervention |