CARBOFLO
Received Dec 11, 2025 · Event occurred Oct 30, 2025
Report 2020394-2025-02162 · MDR key 23776876
Device
Generic name
Eptfe Vascular Graft
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
F8006TWSC
Lot number
VTJW0235
Product problems
- Improper or Incorrect Procedure or Method
- Separation Failure
- Improper or Incorrect Procedure or Method
- Separation Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
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.
Additional Manufacturer Narrative
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: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. 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.
Description of Event or Problem
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.