BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER

    MDR report key: 9921929 · Received April 3, 2020

    Report

    Report Number
    3002648230-2020-00201
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    March 11, 2020
    Report Date
    April 27, 2020
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    UDI-DI
    00763000245436
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE DATA FILES WERE RETURNED AND ANALYZED. THE FILES SHOWED AT LEAST 12 APPLICATIONS WERE PERFORMED WITH THE RETURNED BALLOON CATHETER AFAPRO28 WITH LOT NUMBER 19877 WITHOUT ANY ISSUE ON THE DATE OF THE EVENT. IN CONCLUSION, THE DATA FILES DID NOT INDICATE THAT THERE WERE ISSUES WITH THE BALLOON CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER, AFAPRO28 WITH LOT NUMBER 19877, WAS RETURNED AND ANALYZED. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR 12 INJECTIONS. PERFORMANCE TEST FAILED DUE TO SYSTEM NOTICE 50005 ¿THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION¿ AFTER CONNECTING THE CATHETER TO THE CONSOLE. ALSO, DISSECTION REVEALED A GUIDE WIRE LUMEN (GWL) KINK AND BREACH 0.87 INCHES FROM THE TIP. IN CONCLUSION, THE REPORTED ISSUE WAS CONFIRMED THROUGH TESTING. THE BALLOON CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE GWL KINK AND BREACH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE POTENTIAL ON SOME OF THE ELECTRODES OF THE MAPPING CATHETER DID NOT APPEAR. THE MAPPING CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. ADDITIONALLY, WHEN ATTEMPTING THE REINSERT THE BALLOON CATHETER INTO THE SHEATH, THE INSERTION FAILED. VISUAL INSPECTION OFT HE BALLOON CATHETER SHOWED A KINK IN THE BALLOON SECTION. THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. 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
    386678 ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP AFAPRO28 19877 00763000245436

    Patients

    Seq Age Sex Outcome Treatment
    1