BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 5318763 · Received December 22, 2015

    Report

    Report Number
    3002648230-2015-00472
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    October 7, 2015
    Report Date
    December 16, 2015
    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

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE DEVICE, BALLOON CATHETER 2AF283 WITH LOT NUMBER 49045-45, AND DATA FILES WERE RETURNED AND ANALYZED. DATA FILES CONFIRMED SYSTEM NOTICE 50005, THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION, OCCURRED SEVERAL TIMES FOR THE DATE OF THE PROCEDURE. VISUAL INSPECTION OF THE CATHETER SHOWED BLOOD INSIDE THE BALLOONS. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS NOT USED. DISSECTION AND PRESSURE TESTING SHOWED A GUIDE WIRE LUMEN TWIST AND BREACH AT 3.58 CENTIMETERS PROXIMAL FROM THE TIP. IN CONCLUSION, THE REPORTED ISSUE OF A SYSTEM NOTICE BEING RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION HAS BEEN CONFIRMED THROUGH TESTING. THE CATHETER FAILED THE RETURN PRODUCT INSPECTION DUE TO A GUIDE WIRE LUMEN KINK, TWIST AND BREACH. (B)(4).

    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. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH CRYO. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION UPON MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846000 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283 49045

    Patients

    Seq Age Sex Outcome Treatment
    1