VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE
Report
- Report Number
- 2124215-2026-09277
- Event Type
- Malfunction
- Date Received
- February 19, 2026
- Date of Event
- January 28, 2026
- Report Date
- April 20, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DRE
- UDI-DI
- 00685447019046
- PMA / PMN Number
- K233647
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2B: PRO CODE (PRODUCT CODE) DXF REPORTED HERE PRO CODE EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
CORRECTION TO SECTION G4 PREMARKET / 510(K) D2B: PRO CODE (PRODUCT CODE) DXF REPORTED HERE PRO CODE EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. INVESTIGATION SUMMARY: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC IS UNABLE TO CONFIRM CAUSE OF THE REPORTED CLINICAL OBSERVATION OF STUCK. IT WAS INDICATED THAT THE DEVICE WAS DISPOSED; THEREFORE, A TECHNICAL ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THIS DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS/INSTRUCTIONS FOR USE (IFU). RISK REVIEW A RISK REVIEW PERFORMED FOR THE VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE DEVICE CONFIRMED THAT THE EVENT OF STUCK IS A KNOWN EVENT DEFINED IN THE PRODUCTS RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED AND SUPPORTING EVIDENCE THAT CAME TO THIS CONCLUSION. BOSTON SCIENTIFICS INVESTIGATION FINDINGS WERE UNABLE TO ESTABLISH A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED EVENT. THE DEVICE MET ALL REQUIREMENTS PRIOR TO BEING APPROVED FOR FINAL DISTRIBUTION/SALE AND THERE WAS NO EVIDENCE TO SUGGEST THAT THE INSTRUCTIONS FOR USE (IFU) WAS NOT FOLLOWED.
ADDITIONAL INFORMATION WAS PROVIDED IN SECTION B5 DESCRIBE EVENT OR PROBLEM CORRECTION TO SECTION G4 PREMARKET. D2B: PRO CODE (PRODUCT CODE) DXF REPORTED HERE PRO CODE EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED THAT DURING THE ATRIAL FIBRILLATION ABLATION VC CONNECT FARADRIVE WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT THE THAT PHYSICIAN INSERTED FARADRIVE AND VERSACROSS OVER WIRE AND WIRE BECAME STUCK AND WOULD NOT ADVANCE. AFTER, THERE WAS KINK IN BOTH WIRE AND DILATOR AND FARADRIVE SHEATH. NO PATIENT COMPLICATIONS OCCURRED. THE PROCEDURE WAS COMPLETED USING DIFFERENT DEVICE (SAME MODEL). THE DEVICE IS NOT EXPECTED TO RETURN AS DISCARDED. IT WAS FURTHER REPORTED THAT VERSACROSS DILATOR AND SHEATH WAS KINKED. WIRE WAS NOT SEEN.
IT WAS REPORTED THAT DURING THE ATRIAL FIBRILLATION ABLATION VC CONNECT FARADRIVE WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT THE THAT PHYSICIAN INSERTED FARADRIVE AND VERSACROSS OVER WIRE AND WIRE BECAME STUCK AND WOULD NOT ADVANCE. AFTER, THERE WAS KINK IN BOTH WIRE AND DILATOR AND FARADRIVE SHEATH. NO PATIENT COMPLICATIONS OCCURRED. THE PROCEDURE WAS COMPLETED USING DIFFERENT DEVICE (SAME MODEL). THE DEVICE IS NOT EXPECTED TO RETURN AS DISCARDED. IT WAS FURTHER REPORTED THAT VERSACROSS DILATOR AND SHEATH WAS KINKED. WIRE WAS NOT SEEN. IT WAS FURTHER REPORTED THAT ONLY VERSACROSS DILATOR AND FARADRIVE SHEATH WAS REPLACED TO COMPLETE THE PROCEDURE.
IT WAS REPORTED THAT DURING THE ATRIAL FIBRILLATION ABLATION VC CONNECT FARADRIVE WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT THE THAT PHYSICIAN INSERTED FARADRIVE AND VERSACROSS OVER WIRE AND WIRE BECAME STUCK AND WOULD NOT ADVANCE. AFTER, THERE WAS KINK IN BOTH WIRE AND DILATOR AND FARADRIVE SHEATH. NO PATIENT COMPLICATIONS OCCURRED. THE PROCEDURE WAS COMPLETED USING DIFFERENT DEVICE (SAME MODEL). THE DEVICE IS NOT EXPECTED TO RETURN AS DISCARDED. IT WAS FURTHER REPORTED THAT VERSACROSS DILATOR AND SHEATH WAS KINKED. WIRE WAS NOT SEEN. IT WAS FURTHER REPORTED THAT ONLY VERSACROSS DILATOR AND FARADRIVE SHEATH WAS REPLACED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102910 | VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION | DRE | BOSTON SCIENTIFIC CORPORATION | VXAK0041 | 0037788757 | 00685447019046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |