BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 8580985 · Received May 6, 2019

    Report

    Report Number
    3002648230-2019-00322
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    January 28, 2019
    Report Date
    May 5, 2019
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE BALLOON CATHETER, 2AF283 WITH LOT NUMBER 86168, WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE BALLOON CATHETER SHOWED THAT THE CATHETER WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR 15 APPLICATIONS. THE CATHETER PASSED THE PERFORMANCE TEST AND ELECTRICAL INTEGRITY AS PER SPECIFICATION; IMPEDANCE WAS ALSO WITHIN SPECIFICATION. THE PRESSURE TEST SHOWED A GUIDE WIRE LUMEN (GWL) KINK INSIDE THE CATHETER. DISSECTION SHOWED A GUIDE WIRE LUMEN KINK WAS AT 1.36 INCHES FROM THE TIP INSIDE THE BALLOONS. IN CONCLUSION, THE BALLOON CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO A GWL KINK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AFTER A COMPLETED CASE, THE BALLOON CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377731 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283 86168

    Patients

    Seq Age Sex Outcome Treatment
    1