MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F

Additional Manufacturer Narrative

AS REPORTED, THE SEALANT OF 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) WAS NOT SUCCESSFULLY DEPLOYED AS THE SEALANT WAS STILL FOUND ON THE DISTAL TO THE WHITE TUBING OF THE DEVICE AFTER THE DEVICE WAS WITHDRAWN FROM THE PATIENT¿S BODY. THE DEVICE WAS REMOVED FROM THE PATIENT AND THERE WAS OOZING ON THE ACCESS SITE. PRESSURE WAS THEN HELD TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY AND THE PATIENT DID NOT HAVE ANY COMPLICATIONS. A RETROGRADE APPROACH WAS MADE. THE FEMORAL ARTERY¿S SUITABILITY VERIFIED ON ANGIOGRAPHY OR VENOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THE STICK LOCATION WAS THE COMMON FEMORAL ARTERY. THERE WAS NO PRESENCE OF PVD / CALCIUM IN THE VICINITY OF THE PUNCTURE SITE. THERE WAS NO SCAR TISSUE PRESENT IN THE VICINITY OF THE PUNCTURE SITE. THE DEVICE WAS PROPERLY SHUTTLED DOWN. THE PHYSICIAN RETRACTED THE SHEATH UNTIL THE SHUTTLE LOCKED INTO THE HANDLE AND GRASPED THE ADVANCER TUBE, THEN TAMPED IT FOR 30 SECONDS AND LAID THE DEVICE DOWN FOR 90 SECONDS. THE LSD (LOCK, STABILIZE, DEFLATE) WAS ALSO DONE PRIOR TO REMOVAL OF THE DEVICE. THE DEVICE WAS PROPERLY OPENED IN A STERILE FIELD. THE PRODUCT WAS RETURNED FOR ANALYSIS. A NON-STERILE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F INVOLVED IN THE REPORTED COMPLAINT WAS RETURNED FOR INVESTIGATION. PER VISUAL ANALYSIS, THE SHUTTLE WAS ENGAGED TO THE BLACK HANDLE, THE SYRINGE WAS CONNECTED TO THE DEVICE WITH THE STOPCOCK OPEN, THE PROCEDURE SHEATH WAS ON THE CATHETER, FULLY RETRACTED, THE ADVANCER TUBE WAS DEPLOYED ON THE CATHETER SHAFT, AND THE SEALANT WAS OBSERVED TO HAVE BEEN EXPOSED TO BLOOD COVERING THE BALLOON PROXIMAL TIP AS RECEIVED. THE CONDITION OF THE RETURNED DEVICE INDICATES AN INCOMPLETE REMOVAL OF THE DEVICE. THE RETURNED DEVICE WAS INSPECTED FOR DAMAGES/ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED INCIDENT. NO VISUAL DAMAGES OR ANOMALIES WERE OBSERVED. PER FUNCTIONAL ANALYSIS, THE ADVANCER TUBE WAS PROXIMALLY RETRACTED AND FOUND PROPERLY ENGAGED TO PROXIMAL TAMP LOCK AS INTENDED PER THE MYNXGRIP INSTRUCTIONS FOR USE (IFU). A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F1931503 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿SEALANT DISLODGED¿ WAS CONFIRMED DURING ANALYSIS OF THE RETURNED DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. PROCEDURAL FACTORS, SUCH AS AN INCOMPLETE REMOVAL OF THE DEVICE, MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO THE MYNXGRIP INSTRUCTIONS FOR USE (IFU) WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿REMOVE DEVICE¿, IT INSTRUCTS USERS TO ENSURE COMPLETE BALLOON DEFLATION, THEN SLOWLY WITHDRAW THE BALLOON CATHETER THROUGH THE ADVANCER TUBE LUMEN. FAILURE TO HOLD THE ADVANCER TUBE IN PLACE AND/OR A PROPER POSITION OF THE TAMPING TUBE WAS NOT MAINTAINED DURING CATHETER REMOVAL, THE SEALANT COULD BE DISLODGED FROM THE VESSEL WALL, RESULTING IN THE REPORTED INCIDENT. NEITHER THE PHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem

AS REPORTED, THE SEALANT OF 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) WAS NOT SUCCESSFULLY DEPLOYED AS THE SEALANT WAS STILL FOUND ON THE DISTAL TO THE WHITE TUBING OF THE DEVICE AFTER THE DEVICE WAS WITHDRAWN FROM THE PATIENT¿S BODY. THE DEVICE WAS REMOVED FROM THE PATIENT AND THERE WAS OOZING ON THE ACCESS SITE. THE PRESSURE WAS THEN HELD TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY AND THE PATIENT DID NOT HAVE ANY COMPLICATION. A RETROGRADE APPROACH WAS MADE. FEMORAL ARTERY¿S SUITABILITY VERIFIED ON ANGIOGRAPHY OR VENOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THE STICK LOCATION WAS THE COMMON FEMORAL ARTERY. THERE WERE NO PRESENCE OF PVD / CALCIUM IN THE VICINITY OF THE PUNCTURE SITE. THERE WERE NO SCAR TISSUE PRESENT IN THE VICINITY OF THE PUNCTURE SITE. THE DEVICE WAS PROPERLY SHUTTLED DOWN. THE PHYSICIAN RETRACTED THE SHEATH UNTIL THE SHUTTLE LOCKED INTO THE HANDLE AND GRASPED THE ADVANCER TUBE, THEN TAMPED IT FOR 30 SECONDS AND LAID THE DEVICE DOWN FOR 90 SECONDS. THE LSD (LOCK, STABILIZE, DEFLATE) WAS ALSO DONE PRIOR TO REMOVAL OF THE DEVICE. THE DEVICE WAS PROPERLY OPENED IN A STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION.