BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE

    MDR report key: 3231160 · Received July 17, 2013

    Report

    Report Number
    3002648230-2013-00124
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    PMA / PMN Number
    P020045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED CRYOABLATION CATHETER WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE VISUAL INSPECTION SHOWED THAT THE CATHETER WAS FULL OF BLOOD. THE SHAFT WAS KINKED AT 3.33" AND 4.02" PROXIMAL FROM THE TIP END RESPECTIVELY AND WAS SNAPPED AT 5.46" PROXIMAL FROM THE TIP. SMART CHIP VERIFICATION SHOWED THAT THE CATHETER HAS NOT BEEN USED. WITHOUT REPROGRAMMING THE CATHETER, IT WAS CONNECTED TO THE CONSOLE AND THE CATHETER WAS RECOGNIZED FOLLOWED INSTANTANEOUSLY BY A SYSTEM NOTICE MESSAGE 50005 (THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION). OPTICAL EXAMINATION REVEALED THAT THE PEBAX MATERIAL (FIRST LUMEN) WAS SNAPPED IN HALF. THE ETCHED PTFE LINER WAS NOT SNAPPED BUT PUNCTURED. THE BRAID WIRES WERE DISTORTED AND SOME BROKEN (SHARP EDGE). UNABLE TO DEFLECT THE CATHETER BECAUSE OF THE SNAPPING. FURTHER INVESTIGATION OF THE PULL WIRE SHOWED THAT THE PULL WIRE WAS KINKED AT THE SAME LOCATION WHERE THE SHAFT WAS KINKED AND SNAPPED (3.36", 4.13" AND 5.29" PROXIMAL FROM THE TIP END RESPECTIVELY). NO PULL WIRE BREAKAGE WAS OBSERVED. THE COAXIAL UMBILICAL WAS RETURNED AND SHOWED TRACES OF BLOOD ON THE MALE COAXIAL CONNECTOR (END FACING CATHETER) AND WITHIN THE INJECTION LINE. A CONSOLE CHECK WAS PERFORMED ON SITE DUE TO THE REPORT OF BLOOD IN THE CO-AXIAL UMBILICAL CONNECTOR. THE CONSOLE'S BLOOD BOTTLE, SUB-COOLER, GREEN INJECTION TUBE, AND CLEAR FLOW TUBE WERE REPLACED. THE ST. JUDE MEDICAL FAST-CATH SHEATH WILL BE RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATES THAT THE MEDTRONIC 7FR CRYOABLATION CATHETER WAS BEING USED WITH A ST. JUDE MEDICAL FAST-CATH 7F SHEATH. THE USER REPORTED THAT THE CRYOABLATION CATHETER HAD BEEN DEFLECTED, BUT WOULD NOT UN-DEFLECT. THE USER HAD TROUBLE RETRACTING THE CRYOABLATION CATHETER INTO THE SHEATH AND PULLED HARD TO GET IT INTO THE SHEATH. ONCE RETRACTED AND OUT OF THE SHEATH, THE USER REPORTED THAT THE OUTER COATING OF THE CATHETER HAD SPLIT AND BLOOD WAS IN THE COAXIAL UMBILICAL AND COAXIAL CONNECTOR TO THE CRYOCONSOLE. THE BLOOD WAS WIPED OFF AND OUT OF THE COAXIAL CONNECTOR, A NEW COAXIAL UMBILICAL AND CATHETER WERE PLUGGED IN AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330979 FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP 227F3

    Patients

    Seq Age Sex Outcome Treatment
    1