BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 4140717 · Received October 3, 2014

    Report

    Report Number
    3002648230-2014-00163
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. BIN FILES WERE REVIEWED AND SHOWED THAT AT LEAST 2 INJECTIONS WERE PERFORMED WITH THE CATHETER WITHOUT ANY SYSTEM NOTICE MESSAGES. THE REPORTED ISSUE HAS BEEN CONFIRMED THROUGH VISUAL INSPECTION. THE RETURNED CATHETER FAILED THE INSPECTION DUE TO LEAK AT THE OUTER BALLOON PROXIMAL ATTACHMENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. RESULTS OF EVALUATION OF RETURNED DEVICE WILL BE SUBMITTED IN A SUPPLEMENTAL R EPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ONE CRYOABLATION WAS COMPLETED ON THE LSPV AND WHILE THE PHYSICIAN WAS POSITIONING THE BALLOON FOR THE SECOND ABLATION ON THE LSPV IT MOVED INTO THE LIPV. BALLOON WAS DEFLATED AND REPOSITIONING WAS ATTEMPTED, WITH THE BALLOON STILL DEFLATED, WHEN THE PHYSICIAN NOTED THAT THERE WAS BLOOD COMING OUT THE BACK END OF THE CATHETER. BLOOD WAS ALSO NOTED IN THE COAXIAL CONNECTOR AND AT THE CATHETER/COAXIAL INTERFACE. VACUUM WAS IMMEDIATELY DISABLED ON THE CONSOLE AND BLOOD WAS NOT NOTED NEAR THE CONSOLE CONNECTION. THE CYOABLATION CATHETER AND CABLES WERE IMMEDIATELY REPLACED AND THE CRYOABLATION PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619927 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 20122

    Patients

    Seq Age Sex Outcome Treatment
    1