BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 2990312 · Received March 5, 2013

    Report

    Report Number
    3002648230-2013-00032
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 4, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION. BIN FILES WERE ANALYSIS AND DO NOT SHOW ISSUES FOR THE DATE OF CASE. BIN FILES SHOW THAT AT LEAST 15 INJECTIONS WERE PERFORMED WITH THE CATHETER. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION. THIS REPORT WILL BE RECORDED AND TRENDED. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT HAD A PULMONARY VEIN ISOLATION FIRST WITH A CRYOABLATION CATHETER AND THEN COMPLETED WITH A RADIOFREQUENCY CATHETER. ON FOLLOW-UP EVALUATION, THE PATIENT COMPLAINED OF SHORTNESS OF BREATH. CT SCAN WAS DONE AND SHOWED AN ELEVATED RIGHT SIDE DIAPHRAGM. THE PHYSICIAN MENTIONED THAT THERE WERE NO COMPLICATIONS OF THE PHRENIC NERVE NOTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93197 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Other