BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 5591622 · Received April 20, 2016

    Report

    Report Number
    3002648230-2016-00155
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Date of Event
    January 7, 2016
    Report Date
    April 15, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: THE PATIENT DATA FILES RETURNED WERE CORRUPTED AND UNABLE TO BE ANALYZED. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR THREE INJECTIONS. UPON VISUAL INSPECTION OF THE BALLOON CATHETER 2AF283, LOT # 81335-40, RESULTS SHOW THAT THERE WAS BLOOD INSIDE THE INNER BALLOON. PRESSURE TESTING REVEALED A LEAK THROUGH THE GUIDE WIRE LUMEN AND THE BALLOON¿S INTEGRITY WAS INTACT; NO BREACH OBSERVED. DISSECTION RESULTS SHOWED A GUIDE WIRE LUMEN BREACH AT 0.55 INCHES FROM THE TIP. IN CONCLUSION, THE REPORTED ISSUE HAS BEEN CONFIRMED THROUGH TESTING. THE BALLOON CATHETER FAILED THE INSPECTION DUE TO GUIDE WIRE LUMEN BREACH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243314 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283 81335

    Patients

    Seq Age Sex Outcome Treatment
    1