FDA Adverse Event
Injury
Summary report: N
CARBOFLO VASCULAR GRAFT
MDR report key: 2182538
·
Received July 20, 2011
Report
- Report Number
- 2020394-2011-00164
- Event Type
- Injury
- Date Received
- July 20, 2011
- Report Date
- April 29, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DYF
- PMA / PMN Number
- K004012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND THE LOT MET ALL RELEASE CRITERIA. THE DHR REVIEW SHOWED THAT ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION. THE GRAFT REMAINS IMPLANTED. THEREFORE, A SAMPLE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A VASCULAR GRAFT USED FOR A FEMORO-POPLITIAL BYPASS OCCLUDED SHORTLY AFTER IMPLANT. A THROMBECTOMY WAS SUCCESSFULLY PERFORMED BY INSERTING A CATHETER THROUGH THE GRAFT. REPORTEDLY, UPON CLOSING THE GRAFT, SERIOUS BLEEDING AND NEAR "DISINTEGRATION" OF THE GRAFT WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARBOFLO VASCULAR GRAFT | DYF | BARD PERIPHERAL VASCULAR, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |