CARBOFLO
Report
- Report Number
- 2020394-2025-02161
- Event Type
- Malfunction
- Date Received
- December 11, 2025
- Date of Event
- August 12, 2025
- Report Date
- March 23, 2026
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DYF
- UDI-DI
- 00801741021626
- PMA / PMN Number
- K004011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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. D2B (DYF;DSY) 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: RECEIVED ONE SEALED LOT SAMPLE EPTFE IMPRA VASCULAR GRAFT FOR EVALUATION. UPON VISUAL INSPECTION, NO ANOMALIES WERE NOTED TO THE OUTER PACKAGING. THE DEVICE PACKAGING WAS OPENED, AND NO ANOMALIES WERE NOTED TO ANY OF THE INNER PACKAGING MATERIAL. THE DEVICE WAS REMOVED FROM THE PACKAGING, AND NO ANOMALIES WERE NOTED TO THE DEVICE. THE BEADING WAS NOTED TO BE CORRECT BASED ON THE PRODUCT INFORMATION. DURING FUNCTIONAL TESTING, A SEGMENT WAS CUT OFF ONE END OF THE DEVICE. THE RING OF BEADING WAS GRABBED BY HAND AND WAS PULLED OFF THE DEVICE WITH NO RESISTANCE. A SEGMENT WAS THEN CUT OFF THE OPPOSITE END OF THE GRAFT, AND THE BEADING WAS ALSO ABLE TO BE REMOVED BY HAND WITH NO ISSUE. THE BEADING WAS THEN GRABBED AND STARTED TO BE REMOVED FROM THE REMAINING FULL GRAFT SEGMENT. NO RESISTANCE WAS FELT AND THE BEADING WAS BEING REMOVED WITHOUT ISSUE. HOWEVER, THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED SEPARATION FAILURE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED SEPARATION FAILURE 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. G3, H6 (DEVICE, COMPONENT, METHOD, RESULT, CONCLUSION). SECTION A THROUGH F: THE INFORMATION PROVIDE 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.
ON (B)(6) 2025, A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE USING THE CARBOFLO. DURING THE PROCEDURE THE CLINICIAN WAS UNABLE TO REMOVE THE SPIRAL BEADING FROM GRAFT. THERE WAS NO REPORTED PATIENT INJURY.
ON (B)(6) 2025, A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE USING THE CARBOFLO. DURING THE PROCEDURE THE CLINICIAN WAS UNABLE TO REMOVE THE SPIRAL BEADING FROM GRAFT. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2772510 | CARBOFLO | EPTFE VASCULAR GRAFT | DYF | BARD PERIPHERAL VASCULAR, INC. | VTJW0235 | 00801741021626 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |