BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3853144 · Received June 6, 2014

    Report

    Report Number
    3002648230-2014-00092
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    March 17, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. VISUAL INSPECTION SHOWED THAT THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION INDICATED THAT THE CATHETER HAS NOT BEEN USED. THE CATHETER FAILED THE PERFORMANCE TEST DUE TO SYSTEM NOTICE #12211 "CATHETER NOT RECOGNIZED". THE CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO A BROKEN TC2 WIRE IN THE HANDLE. DISSECTION AND ELECTRICAL CONTINUITY SHOWED THE TC2 WAS BROKEN UNDER THE STRAIN RELIEF IN THE HANDLE AT THE SOLDERING POINT. THE REPORTED ISSUE (# (B)(4)) HAS NOT BEEN CONFIRMED THROUGH TESTING OR DATA ANALYSIS. THIS REPORT WILL BE RECORDED AND TRENDED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT SYSTEM NOTICE MESSAGE 50032 (THE SAFETY SYSTEM HAS DETECTED A COMPROMISED OUTER VAC UUM)OCCURRED DURING A CRYOABLATION PROCEDURE. THE CATHETER WAS REPLACED AND THE CRYOABLATION PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332692 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283 64054

    Patients

    Seq Age Sex Outcome Treatment
    1