VERSACROSS ACCESS SOLUTION

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PULSE FIELD ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT THE COATING CAME OFF IN THE MIDDLE OF VERSACROSS WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A DIFFERENT DEVICE (SAME MODEL, BOSTON SCIENTIFIC PRODUCT). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED. IT WAS FURTHER REPORTED, THE DAMAGE WAS OBSERVED AFTER THE WIRE AND DILATOR WERE REMOVED. THE WIRE WAS PULLED BACK INTO THE SHEATH/ DILATOR ONCE THE SHEATH WAS IN THE SUPERIOR VENA CAVA (SVC). THE WIRE WAS THEN PULLED BACK AGAIN WHEN REMOVED. THE DILATOR WAS ALREADY BACKLOADED ONTO THE WIRE/INSIDE THE PATIENT

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PULSE FIELD ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT THE COATING CAME OFF IN THE MIDDLE OF VERSACROSS WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A DIFFERENT DEVICE (SAME MODEL, BOSTON SCIENTIFIC PRODUCT). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED.