BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 8604125 · Received May 13, 2019

    Report

    Report Number
    3002648230-2019-00351
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    April 17, 2019
    Report Date
    July 1, 2019
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE BALLOON CATHETER, 2AF283 WITH LOT NUMBER 50657, WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE BALLOON CATHETER SHOWED THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. VERIFICATION OF THE SMART CHIP FILE INDICATED THE CATHETER WAS USED FOR 7 APPLICATIONS. THE BALLOON CATHETER PASSED THE PERFORMANCE TEST, THE ELECTRICAL INTEGRITY TEST AS PER SPECIFICATION AND THE IMPEDANCE WAS WITHIN SPECIFICATION. THE DISSECTION TEST SHOWED THE GUIDE WIRE LUMEN (GWL) KINK 1.1 INCHES FROM THE TIP OF THE CATHETER. IN CONCLUSION, THE REPORTED GWL KINK WAS CONFIRMED THROUGH TESTING. THE CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE GWL KINK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AFTER INSERTING THE BALLOON CATHETER INTO THE SHEATH AND OPENING THE BALLOON, THERE WAS A BEND IN THE BALLOON CATHETER, AND IT COULD NOT BE USED CORRECTLY. INCOMING INFORMATION INDICATED A KINK IN THE GUIDEWIRE LUMEN. THE BALLOON CATHETER WAS REPLACED WITH RESOLVE. THE CASE 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
    397304 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283 50657

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR