BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER

    MDR report key: 8770880 · Received July 9, 2019

    Report

    Report Number
    3002648230-2019-00486
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 9, 2019
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE BALLOON CATHETER, AFAPRO28 WITH LOT NUMBER 31507, WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE BALLOON CATHETER SHOWED THE CATHETER WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR 7 APPLICATIONS ON THE DATE OF THE EVENT. THE CATHETER PASSED THE INTEGRITY AND PERFORMANCE TEST THERE WAS NO KINK OR BEND IN GUIDE WIRE LUMEN (GWL) INSIDE THE BALLOON SEGMENT. THE STEERING MECHANISM WORKS PROPERLY. PRESSING THE PUSH BUTTON ALSO DIDN¿T KINKED THE GWL. IN CONCLUSION, THE REPORTED GWL KINK WAS NOT CONFIRMED THROUGH TESTING. THE BALLOON CATHETER PASSED THE RETURNED PRODUCT INSPECTION. 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 CRYOABLATION PROCEDURE, WHEN SETTING UP THE BALLOON CATHETER, A BEND WAS NOTED IN THE GUIDEWIRE LUMEN. 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
    567735 ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP AFAPRO28 31507

    Patients

    Seq Age Sex Outcome Treatment
    1