FDA Adverse Event
Injury
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 3111934
·
Received June 29, 2006
Report
- Report Number
- 2953144-2006-00161
- Event Type
- Injury
- Date Received
- June 29, 2006
- Date of Event
- May 31, 2006
- Report Date
- May 31, 2006
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- MGB
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF VISUAL EVALUATION AND TESTING ON THE RETURNED SAMPLE INDICATE THAT A BOND FAILURE OCCURRED. HOWEVER, BASED ON AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE IDENTIFIED. CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE.
Description of Event or Problem · 1
ON (B)(6) 2006, A PHYSICIAN ATTEMPTED A FEMORAL ARTERIOTOMY CLOSURE USING A STARCLOSE. THE DEVICE BECAME STUCK IN THE LEG, AND WAS REMOVED VIA SURGERY. THE ARTERIOTOMY WAS CLOSED WITH SUTURES. THERE WAS NO FURTHER INJURY OR TREATMENT TO THE PATIENT, WHO WAS HOSPITALIZED 2 EXTRA DAYS AND WAS DISCHARGED HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE VASCULAR CLOSURE SYSTEM | VASCULAR CLOSURE SYSTEM | MGB | ABBOTT VASCULAR INC. | NA | 37164-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |