BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 3211291 · Received July 8, 2013

    Report

    Report Number
    1058196-2013-00180
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 18, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15775362 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(4).

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, AFTER PLACING THE PROWLER SELECT PLUS (MC) MICROCATHETER AT THE SITE, THE ENTERPRISE VRD COULD NOT BE ADVANCED AND RELEASED. THE MC AND VRD SYSTEM WERE REMOVED TOGETHER, AND THE TIP OF THE MC WAS OUT OF SHAPE (COMPRESSED). THE STENT COULD NOT CONTINUE TO USE. FINALLY THE PHYSICIAN CHANGED NEW MC AND STENT TO COMPLETE THE PROCEDURE WITHOUT ANY ADVERSE EVENT REPORTED. DURING INSERTION, THE ENTERPRISE INTRODUCER WAS COMPLETELY SEATED IN THE MICROCATHETER HUB, AND THE Y CONNECTOR OPEN SUFFICIENTLY TO ALLOW THE PASSAGE OF THE COIL DELIVERY SYSTEM/INTRODUCER. DURING INSERTION, THE TUOHY OR Y CONNECTOR WAS CLOSED TO SECURE THE COIL DELIVERY SYSTEMS/INTRODUCERS AND PREVENT MOVEMENT, AND IT IS UNKNOWN IF THE Y CONNECTOR WAS OVER TIGHTENED. NO DAMAGES WERE NOTICED ON ANY SECTION OF THE DELIVERY SYSTEM THAT MAY HAVE CONTRIBUTED TO THE EVENT, AND NO ISSUES WERE NOTED DURING REMOVAL FROM THE PLASTIC HOOP THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL TORQUE OR MANIPULATION WAS REQUIRED TO ADVANCED OR PLACE THE MICROCATHETER, AND THE DISTAL TIP WAS NOT RESHAPED. A CONSTANT AND DEDICATED SALINE SOURCE WAS USED AT ALL TIMES THROUGH THE MICROCATHETER. AFTER THE EVENT, NO OTHER DAMAGES WERE NOTICED ON THE DEVICES (ENTERPRISE DELIVERY SYSTEM/DISTAL TIP (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, SEPARATED, ETC), OR STENT (STRUT UPLIFT OR DEFORMED, ETC). THE TARGET SITE WAS AN INTRACRANIAL ANEURYSM. THE DEVICES WILL BE RETURNED FOR ANALYSES. A NON-STERILE SELECT PLUS 150/5 CM WAS RECEIVED COILED INSIDE A BOX. THE MICROCATHETER WAS INSPECTED AND IT WAS FOUND COMPRESSED. THE MICROCATHETER WAS INSPECTED UNDER MICROSCOPE AND THE COMPRESSED SECTIONS FOUND ON THE VISUAL ANALYSIS WERE CONFIRMED. THE ID FROM THE MICROCATHETER WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE (NIPRO) AND AFTER THAT A 0.018¿ A GUIDE WIRE LAB SAMPLE WAS INTRODUCED INTO THE MICROCATHETER AND IT ADVANCE SMOOTHLY UNTIL THE MICROCATHETER'S DISTAL TIP; RESISTANCE/FRICTION WAS FELT WHEN THE GUIDE WIRE WAS PASS THROUGH OF THE COMPRESSED SECTIONS FOUND ON THE MICROCATHETER. AFTER THAT THE MICROCATHETER WAS FLUSHED AGAIN AND A LAB SAMPLE ENTERPRISE WAS INTRODUCED INTO THE MICROCATHETER AND IT ADVANCE SMOOTHLY UNTIL IT WAS STUCK AT 125CM FROM THE PROXIMAL END OF HUB AND COULD NOT MOVE MORE, SO IT WAS REMOVED FROM THE DEVICE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED FAILURE OF FAILURE TO ADVANCE ENTERPRISE SYSTEM IN THE VRD CANNOT BE EVALUATED AS IS REQUIRED DUE TO THE INVOLVED STENT WAS NOT RECEIVED; THE CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER MIGHT BE RELATED TO THE FLAT/COMPRESSED SECTION OBSERVED ON THE INVOLVED MICROCATHETER. HOWEVER, THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD NOT BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE FAILURES ON THE MICROCATHETER OF OBSTRUCTED AND COMPRESSED WERE CONFIRMED DURING THE FUNCTIONAL ANALYSIS. THE CAUSE OF THE FAILURE EXPERIENCED BY THE COSTUMER APPEARS WAS DUE TO THE COMPRESSED SECTIONS FOUND ON THE DEVICE BUT THIS AND THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD NOT BE RELATED TO THE MANUFACTURING PROCESS; ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING TREATMENT OF AN INTRACRANIAL ANEURYSM (4*4MM) WITH A NECK OF THE ANEURYSM WAS TOO WIDE THE STENT WAS NEEDED TO ASSIST FILLING, BUT THE ENTERPRISE VRD (ENC451412/10156885) COULD NOT BE ADVANCED AND RELEASED VIA THE PROWLER SELECT PLUS (MC) MICROCATHETER (606S255X/ 15775362). THEN, THE MC WAS REMOVED TOGETHER WITH THE VRD AND IT WAS OBSERVED THAT THE TIP OF THE MC WAS OUT OF SHAPE. THE STENT COULD NOT CONTINUE TO BE USED. FINALLY, THE MC AND STENT TO WERE CHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED AND THE DEVICES WILL BE RETURNED FOR ANALYSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310965 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15775362

    Patients

    Seq Age Sex Outcome Treatment
    1 ENTERPRISE VRD