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

CORRECTION TO THE INITIAL MDR IN BLOCK H6. THE REPORTED ALLEGATIONS ARE NOT CONFIRMED AS THE DEVICE WAS NOT RETURNED AND NO MEDIA HAS BEEN PROVIDED. DHR/SERVICE HISTORY REVIEW: THE DHR FOR THE DILATOR, 37994334, 37999128, 38045943, 38135682, AND 38149384, WERE REVIEWED. THERE WAS NO INDICATION THAT A DEVIATION OR NONCONFORMANCE ASSOCIATED WITH THE MANUFACTURING PROCESS CONTRIBUTED TO THIS EVENT. ADDITIONAL REVIEW IS NOT REQUIRED. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE DEVICE CONFIRMED THAT THE EVENT OF VESSEL TRAUMA, HEMORRHAGE IS A KNOWN EVENT DEFINED IN THE PRODUCT RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. PRODUCT RISK BENEFIT INCLUDES CONSIDERATION OF RISK SEVERITY AND RATE, AND THE OVERALL RESIDUAL RISK OF THE VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE DEVICE IS ACCEPTABLE. LABELING REVIEW: THE INSTRUCTIONS FOR USE WERE REVIEWED, AND IT DID NOT REVEAL ANY EVIDENCE OF DEVICE OFF LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. THE IFU MENTIONS: "VESSEL TRAUMA AND HEMORRHAGE". THERE IS NO EVIDENCE THAT ANY UPDATES TO THE DOCUMENT ARE REQUIRED AT THIS TIME. THE INFORMATION WITHIN THE EVENT DESCRIPTION SUGGESTS THAT THE CLINICAL EVENT IS ANTICIPATED IN NATURE AS PER THE IFU AS REPORTED TO BSC. AT THIS POINT, IT CAN BE CONCLUDED THAT "KNOWN INHERENT RISKS OF DEVICE" USE MOST PROBABLY CONTRIBUTED TO THE EVENTS ADVERSE EVENT. LEADING POTENTIAL CAUSES INCLUDE PATIENT ANATOMY AND PHYSICIAN TECHNIQUE. THERE IS NO EVIDENCE MANUFACTURING CAUSED OR CONTRIBUTED.

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.

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.