BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3802358 · Received May 9, 2014

    Report

    Report Number
    3002648230-2014-00079
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED AND PASSED THE RETURNED PRODUCT INSPECTION AS PER SPECIFICATION. VISUAL INSPECTION SHOWED THAT THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR 11 INJECTIONS. THE CATHETER PASSED THE PERFORMANCE TEST AND ELECTRICAL INTEGRITY AS PER SPECIFICATION; IMPEDANCE WAS ALSO WITHIN SPECIFICATION. DISSECTION/PRESSURE TESTS DID NOT SHOW ANY LEAKS OR TRACES OF LIQUID/BLOOD INSIDE THE CATHETER. AN INTERNAL CAPA HAS BEEN INITIATED TO INVESTIGATE THE RISK OF CARDIAC PERFORATION, PERICARDIAL EFFUSION AND TAMPONADE ASSOCIATED WITH CRYOABLATION FOR ATRIAL FIBRILLATION. THIS REPORT WILL BE RECORDED AND TRENDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN ANALYZED. RESULTS OF EVALUATION OF RETURNED DEVICE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PATIENT DEVELOPED A PERICARDIAL EFFUSION DURING A CRYOABLATION PROCEDURE. PERICARDIAL EFFUSION OCCURRED BETWEEN THE THIRD AND FOURTH ABLATIONS. PATIENT ALSO REPORTED AS HAVING LOW BLOOD PRESSURE. THE PROCEDURE WAS ABORTED TO PERFORM PERICARDIOCENTESIS. DEVICE 1 OF 2, REFERENCE MFR REPORT: 3002648230-2014-00080.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281696 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 06359

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention