VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE

Description of Event or Problem

DURING A PULSE FIELD ABLATION (PFA) A FARADRIVE STEERABLE SHEATH CLEAR AND VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE WAS SELECTED FOR USE. PFA AF ABLATION. RIGHT FEMORAL ACCESS WAS OBTAINED USING A SHORT 6FR SHEATH AND A 7FR SHEATH UNDER ULTRASOUND GUIDANCE, AND HEPARIN WAS ADMINISTERED. THE VERSACROSS CONNECT (VCC) PIGTAIL WAS ADVANCED, FOLLOWED BY EXCHANGING THE VCC WITH DILATOR OVER THE 6FR SHEATH. THERE WAS DIFFICULTY ADVANCING THE SHEATH OVER THE WIRE, LEADING TO THE USE OF PERIPHERAL DILATORS. THE TEAM THEN SWITCHED FROM THE VCC DILATOR TO THE FD DILATOR, WHICH PROVIDED SOME IMPROVEMENT, BUT ADVANCEMENT WAS STILL UNSUCCESSFUL. SIGNIFICANT BLEEDING DEVELOPED AT THE PUNCTURE SITE, AND THE FIRST ACT MEASURED 406 SECONDS. IT WAS DETERMINED THAT A SMALL ARTERIOLE HAD BEEN PUNCTURED AND POSSIBLY WIRED, RESULTING IN A LIKELY SMALL VESSEL TEAR THAT WAS MANAGED WITH MANUAL PRESSURE. AN ATTEMPT WAS MADE TO OBTAIN LEFT FEMORAL VEIN ACCESS, BUT ULTRASOUND SHOWED THE FEMORAL ARTERY POSITIONED ABOVE THE VEIN, PREVENTING ACCESS. THE PROCEDURE WAS ABORTED, HEPARIN WAS REVERSED WITH PROTAMINE, AND ANESTHESIA WAS DISCONTINUED WITH THE PATIENT EXTUBATED IN THE EP LAB. THE PATIENT WAS ADMITTED FOR OVERNIGHT MONITORING AND HEMOSTASIS. THE PATIENT WAS PRESENT DURING THE EVENT AND EXPERIENCED BLEEDING, THOUGH THE PHYSICIAN DID NOT BELIEVE THE DEVICE OR PROCEDURE CAUSED OR CONTRIBUTED TO THE COMPLICATION. A COMPRESSION DEVICE WAS APPLIED TO THE RIGHT FEMORAL ARTERIAL PUNCTURE SITE. THE PATIENT REQUIRED HOSPITAL ADMISSION BEYOND STANDARD CARE AND HAD NOT YET BEEN DISCHARGED, BUT WAS EXPECTED TO FULLY RECOVER. THE PROCEDURE WAS UNSUCCESSFUL DUE TO THE INABILITY TO ADVANCE THE SHEATH TO THE HEART FROM EITHER FEMORAL VEIN. AT THE TIME THE PROCEDURE WAS CANCELLED, THE PATIENT WAS UNDER GENERAL ANESTHESIA.

Additional Manufacturer Narrative

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.