VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE
Report
- Report Number
- 2124215-2026-11649
- Event Type
- Injury
- Date Received
- March 3, 2026
- Date of Event
- February 9, 2026
- Report Date
- April 14, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DXF
- UDI-DI
- 00685447019046
- PMA / PMN Number
- K150709
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2B: PRO CODE (PRODUCT CODE): DXF; REPORTED HERE AS THE PRO CODE (PRODUCT CODE) EXCEEDED THE 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 D2B PRO CODE AND G4 PREMARKET. INVESTIGATION SUMMARY. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC IS UNABLE TO CONFIRM CAUSE OF THE REPORTED CLINICAL OBSERVATION OF FAILURE TO CROSS SEPTUM AND DIFFICULT/FAILURE TO VISUALIZE DEVICE. ALTHOUGH THE PRODUCT WAS DISPOSED OF AND COULD NOT BE RETURNED, WE HAVE DETERMINED THAT THE CARDIAC TAMPONADE, PERICARDIAL EFFUSION AND HYPOTENSION ARE KNOWN INHERENT RISK OF USE OF THIS DEVICE. 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 FAILURE TO CROSS SEPTUM AND DIFFICULT/FAILURE TO VISUALIZE DEVICE ARE KNOWN EVENTS DEFINED IN THE PRODUCTS RISK MANAGEMENT DOCUMENTATION. THE CARDIAC TAMPONADE, PERICARDIAL EFFUSION AND HYPOTENSION ARE KNOWN INHERENT RISKS OF USE OF THIS DEVICE. THESE EVENT TYPES HAVE 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 KNOWN INHERENT RISK OF DEVICE AND CAUSE NOT ESTABLISHED SUPPORTING EVIDENCE THAT CAME TO THIS CONCLUSION. BASED ON THE INFORMATION PROVIDED, THE REPORTED EVENT OF CARDIAC TAMPONADE, PERICARDIAL EFFUSION AND HYPOTENSION ARE KNOWN INHERENT RISK OF THE VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE DEVICE. CARDIAC TAMPONADE, PERICARDIAL EFFUSION AND HYPOTENSION ARE EXPECTED PROCEDURAL COMPLICATION ADDRESSED WITHIN THE IFU FOR THE VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE. BOSTON SCIENTIFIC WAS UNABLE TO CONFIRM CAUSE OF THE REPORTED CLINICAL OBSERVATION OF FAILURE TO CROSS SEPTUM AND DIFFICULT/FAILURE TO VISUALIZE DEVICE, AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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.
IT WAS REPORTED THAT DURING A FARAPULSE PULMONARY VEIN ISOLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, AN ISSUE OCCURRED FOLLOWING ADMINISTRATION OF GENERAL ANESTHESIA DURING AN ATTEMPT AT TRANSSEPTAL ACCESS USING A VERSACROSS CONNECT FOR FARADRIVE WITH A PIGTAIL RF WIRE AND FARADRIVE STEERABLE SHEATH. WHILE POSITIONING THE VERSACROSS CONNECT SYSTEM, INTRACARDIAC ECHOCARDIOGRAPHY AND FLUOROSCOPY WERE USED. HOWEVER, THE PATIENT ANATOMY MADE VISUALIZATION DIFFICULT. THE RF WIRE WAS POSITIONED AGAINST THE SEPTUM AND CROSSING WAS ATTEMPTED, BUT THE RF WIRE DID NOT CROSS INTO THE LEFT ATRIUM. THE SYSTEM WAS REPOSITIONED FOR A SECOND ATTEMPTED CROSSING. HOWEVER, AT THIS TIME THE PATIENT EXPERIENCED HYPOTENSION AS THEIR BLOOD PRESSURE DROPPED TO 50 TO 60 MMHG. DIAGNOSTIC IMAGING SHOWED A PERICARDIAL EFFUSION AND/OR CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED REMOVING 300 ML OF BLOOD FROM THE PERICARDIAL SPACE. THE PROCEDURE WAS CANCELLED, THE PATIENT WAS STABILIZED, AND THEY WERE ADMITTED TO THE INTENSIVE CARE UNIT FOR OVERNIGHT EVALUATION. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE VERSACROSS CONNECT SYSTEM WAS DISCARDED AND IS NOT EXPECTED TO RETURN.
IT WAS REPORTED THAT DURING A FARAPULSE PULMONARY VEIN ISOLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, AN ISSUE OCCURRED FOLLOWING ADMINISTRATION OF GENERAL ANESTHESIA DURING AN ATTEMPT AT TRANSSEPTAL ACCESS USING A VERSACROSS CONNECT FOR FARADRIVE WITH A PIGTAIL RF WIRE AND FARADRIVE STEERABLE SHEATH. WHILE POSITIONING THE VERSACROSS CONNECT SYSTEM, INTRACARDIAC ECHOCARDIOGRAPHY AND FLUOROSCOPY WERE USED. HOWEVER, THE PATIENT ANATOMY MADE VISUALIZATION DIFFICULT. THE RF WIRE WAS POSITIONED AGAINST THE SEPTUM AND CROSSING WAS ATTEMPTED, BUT THE RF WIRE DID NOT CROSS INTO THE LEFT ATRIUM. THE SYSTEM WAS REPOSITIONED FOR A SECOND ATTEMPTED CROSSING. HOWEVER, AT THIS TIME THE PATIENT EXPERIENCED HYPOTENSION AS THEIR BLOOD PRESSURE DROPPED TO 50 TO 60 MMHG. DIAGNOSTIC IMAGING SHOWED A PERICARDIAL EFFUSION AND/OR CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED REMOVING 300 ML OF BLOOD FROM THE PERICARDIAL SPACE. THE PROCEDURE WAS CANCELLED, THE PATIENT WAS STABILIZED, AND THEY WERE ADMITTED TO THE INTENSIVE CARE UNIT FOR OVERNIGHT EVALUATION. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE VERSACROSS CONNECT SYSTEM WAS DISCARDED AND IS NOT EXPECTED TO RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51765 | VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION | DXF | BOSTON SCIENTIFIC CORPORATION | VXAK0041 | 0037824510 | 00685447019046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |