CARBOFLO
Report
- Report Number
- 2020394-2025-01668
- Event Type
- Malfunction
- Date Received
- October 15, 2025
- Date of Event
- September 22, 2025
- Report Date
- December 18, 2025
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DSY
- UDI-DI
- 00801741021596
- PMA / PMN Number
- K004011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H11: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: ONE IMPRA CARBOFLO GRAFT WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, THE COMPLAINT SAMPLE RETURNED APPEARED TO HAVE RESIDUE THROUGHOUT. THE GRAFT APPEARED TO HAVE BEEN CUT ON BOTH ENDS. WHAT APPEARED LIKE CRIMP MARKS, WERE NOTED ON PROXIMAL END OF THE GRAFT. WHAT APPEARED TO BE A COMPLETE DIAGONAL BREAK, WAS NOTED ON THE DISTAL END OF THE GRAFT. THE REMAINING PORTION/SEGMENT OF THE GRAFT WAS NOT RETURNED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MATERIAL TORN AS DIAGONAL BREAK WAS NOTED ON THE DISTAL END OF THE GRAFT. A DEFINITIVE ROOT CAUSE FOR THE REPORTED TORN ISSUE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. D2B (DSY: DYF), G3, H6 (COMPONENT, METHOD, RESULT, CONCLUSION) SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
A PATIENT WAS GETTING PREPARED FOR A SURGICAL GRAFT PLACEMENT PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE MATERIAL TORE REPEATEDLY WHILE STITCHING. THERE WAS NO PATIENT CONTACT.
A PATIENT WAS GETTING PREPARED FOR A SURGICAL GRAFT PLACEMENT PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE MATERIAL TORE REPEATEDLY WHILE STITCHING. THERE WAS NO PATIENT CONTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2019210 | CARBOFLO | EPTFE VASCULAR GRAFT | DSY | BARD PERIPHERAL VASCULAR, INC. | VTJZ0360 | 00801741021596 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |