BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3152864 · Received June 8, 2013

    Report

    Report Number
    3002648230-2013-00086
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED CATHETER WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. FAILURE FILES WERE REVIEWED AND CONFIRMED THE SYSTEM NOTICE MESSAGE 50005 ¿LEAK DETECTION¿ FOR THE DATE OF CASE. VISUAL INSPECTION SHOWED THAT THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR 12 INJECTIONS. THE CATHETER FAILED THE PERFORMANCE TEST DUE TO SYSTEM NOTICE #50005 UPON CONNECTION. PRESSURE TEST SHOWED A LEAK THROUGH THE GUIDE WIRE LUMEN, HOWEVER, THE BALLOONS INTEGRITY WAS INTACT; NO BREACH OBSERVED. DISSECTION SHOWED A GUIDE WIRE LUMEN PARTIAL SNAPPING AT 0.50 INCHES PROXIMAL FROM THE TIP AS WELL AS GUIDE WIRE LUMEN KINK AT 1.43 INCHES. THE KINK IN THE GUIDE WIRE LUMEN WAS MAKING THE DISTAL SEGMENT BEND, INCREASING DIFFICULTY FOR SHEATH INSERTION/WITHDRAWAL. AN INTERNAL CAPA HAS BEEN INITIATED TO INVESTIGATE THE CONDITION FOUND. THIS REPORT WILL BE RECORDED AND TRENDED.

    Description of Event or Problem · 1

    THE PHYSICIAN RETRACTED THE CRYOBALLOON CATHETER INTO THE STEERABLE SHEATH. UPON ATTEMPTING TO ADVANCE THE BALLOON CATHETER BACK OUT OF THE SHEATH, FOUND THAT IT WOULD NOT ADVANCE OUT. THE CATHETER WAS REMOVED WITHOUT INCIDENT. AS THE PHYSICIAN WAS EXAMINING THE TIP OF THE CATHETER, SYSTEM NOTICE MESSAGE 50005 (THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION) WAS TRIGGERED. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED WITHOUT INCIDENT. WHEN THE DEVICE WAS RETURNED, PRESSURE TESTING REVEALED A LEAK THROUGH THE GUIDE WIRE LUMEN. REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254996 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284

    Patients

    Seq Age Sex Outcome Treatment
    1