BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 4180698 · Received October 17, 2014

    Report

    Report Number
    3002648230-2014-00170
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    July 11, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. VISUAL INSPECTION SHOWED THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR 15 INJECTIONS. THE REPORTED ISSUE HAS BEEN CONFIRMED THROUGH TESTING. THE CATHETER FAILED THE PERFORMANCE TEST DUE TO SYSTEM NOTICE MESSAGE 50005. DISSECTION / PRESSURE TESTS REVEALED A GUIDE WIRE LUMEN KINK AND BREACH AT 1.45 INCHES PROXIMAL FROM THE TIP.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT SYSTEM NOTICE MESSAGE 50005 (THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION) OCCURRED DURING A CRYOABLATION PROCEDURE. THE SYSTEM NOTICE MESSAGE OCCURRED BEFORE ABLATION IN THE RIGHT INFERIOR PULMONARY VEIN, AFTER ABLATIONS IN THE LEFT PULMONARY VEINS HAD BEEN COMPLETED. THE CATHETER WAS REPLACED AND THE CRYOABLATION PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS RELATED TO THE EVENT. WHEN THE DEVICE WAS RETURNED, PRESSURE TESTING REVEALED A GUIDE WIRE LUMEN BREACH. REPORTABLE BASED ON ANALYSIS COMPLETED ON 09/23/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662730 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283 52927

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR