BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 8580986 · Received May 6, 2019

    Report

    Report Number
    3002648230-2019-00323
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    February 1, 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 94020, WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE BALLOON CATHETER SHOWED THE GUIDE WIRE LUMEN WAS KINKED AT THE BALLOON SEGMENT. VERIFICATION OF THE SMART CHIP FILE INDICATED THE CATHETER WAS USED FOR 17 INJECTIONS. THE CATHETER FAILED THE PERFORMANCE TEST DUE TO SYSTEM NOTICE (B)(4) WHICH WAS TRIGGERED IMMEDIATELY WHEN CONNECTED TO THE CONSOLE. THE DISSECTION TEST SHOWED THE GUIDE WIRE LUMEN (GWL) KINK AND TWIST AT 2.01 INCHES FROM THE TIP OF THE CATHETER AND ANOTHER KINK AT 1.1 INCHES FROM THE TIP OF THE CATHETER. PRESSURE TEST SHOWED A BREACH AT THE GWL KINK AT 1.1 INCH, THE BREACH COULD HAVE OCCURRED DURING THE MANIPULATION TO REMOVE THE CATHETER FROM THE SHEATH. IN CONCLUSION, THE BALLOON CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE GWL KINK AND BREACH. 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
    374303 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283 94020

    Patients

    Seq Age Sex Outcome Treatment
    1