BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 5772579 · Received July 6, 2016

    Report

    Report Number
    3002648230-2016-00263
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    March 22, 2016
    Report Date
    June 16, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE, ARCTIC FRONT ADVANCE BALLOON CATHETER 2AF283 WITH LOT NUMBER 81337-35, AND DATA FILES WERE RETURNED AND ANALYZED. DATA FILES DID NOT SHOW ANY SYSTEM NOTICES FOR THE DATE OF THE PROCEDURE. VISUAL INSPECTION OF THE BALLOON CATHETER SHOWED THERE WAS BLOOD INSIDE THE INNER BALLOON. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR SEVEN INJECTIONS. PRESSURE TESTING REVEALED A LEAK THROUGH THE GUIDE WIRE LUMEN. THE BALLOON INTEGRITY WAS INTACT. DISSECTION SHOWED A GUIDE WIRE LUMEN BREACH AT 1.37 INCHES FROM THE TIP. IN CONCLUSION, THE REPORTED ISSUE WAS CONFIRMED THROUGH TESTING AND THE CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO A GUIDE WIRE LUMEN BREACH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. BOTH OF THE UMBILICAL CABLES WERE REPLACED TO NO AVAIL. THE BALLOON CATHETER WAS THEN REPLACED WITH RESOLVE. THE PROCEDURE WAS COMPLETED WITH CRYO. THE BALLOON WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425979 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283 81337

    Patients

    Seq Age Sex Outcome Treatment
    1