BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 5692941 · Received June 1, 2016

    Report

    Report Number
    3002648230-2016-00214
    Event Type
    Malfunction
    Date Received
    June 1, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 1, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: UPON VISUAL INSPECTION OF CATHETER 2AF283 / 29918-08 SHOWED THE INNER BALLOON HAD TRACES OF BLOOD INSIDE, HOWEVER, THERE WAS NO BLOOD INSIDE THE CATHETER HANDLE. PRESSURE TESTS REVEALED A LEAK THROUGH THE GUIDE WIRE LUMEN. THE BALLOON INTEGRITY WAS INTACT AND NO BREACH OBSERVED. DISSECTION SHOWED A GUIDE WIRE LUMEN KINK AND GUIDE WIRE LUMEN BREACH AT APPROXIMATELY 1.375 INCHES PROXIMAL FROM THE TIP. IN CONCLUSION, THE BALLOON CATHETER FAILED THE INSPECTION DUE TO A KINK AND GUIDE WIRE LUMEN BREACH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, THE ELECTRODES TWO AND THREE OF THE MAPPING CATHETER STOPPED WORKING. THE MAPPING CATHETER WAS REPLACED RESOLVING THE ISSUE. ADDITIONALLY, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE BALLOON CATHETER WAS THEN REPLACED AND THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. UPON ANALYSIS, THE CRYO BALLOON TESTED OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345624 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 2AF283 29918

    Patients

    Seq Age Sex Outcome Treatment
    1