BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 7238410 · Received February 2, 2018

    Report

    Report Number
    3002648230-2018-00063
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    June 28, 2017
    Report Date
    February 8, 2018
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: UPON VISUAL INSPECTION OF CATHETER 2AF283/61633-80, RESULTS SHOWED THAT THE CATHETER WAS INTACT WITHOUT ANY ISSUES. SMART CHIP VERIFICATION INDICATED THE CATHETER HAS BEEN USED FOR SEVEN APPLICATIONS. THE CATHETER FAILED THE PERFORMANCE TEST DUE TO HIGH PRESSURE. PRESSURE/DISSECTION SHOWED A GUIDE WIRE LUMEN WAS KINKED AND TWISTED PROXIMAL TO THE COILED SECTION OF THE INJECTION TUBE. X-RAY INSPECTION OF THE GUIDE WIRE LUMEN SHOWED WHAT APPEAR AT FRAGMENT FROM THE PEBAX SHAFT OF THE ACHIEVE. X-RAY CONFIRMED ALL THE ELECTRODES (08) WERE ENTRAPPED ALL LONG THE GUIDE WIRE LUMEN. IN CONCLUSION, THE REPORTED CATHETER 2AF283/61633-80 FAILED THE INSPECTION DUE GUIDE WIRE LUMEN TWIST AND KINK AND ENTRAPMENT OF ELE CTRODES (08 ELECTRODES).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN UNKNOWN COMPLAINT DURING A CRYO PROCEDURE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. UPON ANALYSIS OF THE PRODUCT AND RETURN, BOTH THE BALLOON CATHETER AND THE MAPPING CATHETER TESTED OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OUT OF SPECIFICATION FINDING WAS DISCOVERED, FOLLOWING ANALYSIS OF THE BALLOON CATHETER, AS IT WAS RETURNED. 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
    80874 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283 61633

    Patients

    Seq Age Sex Outcome Treatment
    1