BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3181588 · Received June 21, 2013

    Report

    Report Number
    3002648230-2013-00097
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE. BIN FILES WERE REVIEWED AND DO NOT SHOW ISSUES OR SYSTEM NOTICES FOR DEVICE (B)(4). BIN FILES SHOW THAT AT LEAST 23 INJECTIONS WERE PERFORMED WITH THE CATHETER.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT A PATIENT HAD AN ESOPHAGEAL ULCERATION POST CRYOABLATION PROCEDURE. PATIENT PRESENTED TO EMERGENCY ROOM ON (B)(6) 2013 WITH ESOPHAGEAL BLEEDING. PATIENT WAS EVALUATED AND IT WAS DETERMINED THAT ESOPHAGEAL ULCERATION WAS PRESENT. THE PATIENT WAS TREATED AND DISCHARGED (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282261 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 00065 YR Hospitalization