BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2103089 · Received May 25, 2011

    Report

    Report Number
    3002648230-2011-00032
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED ISSUE WAS CONFIRMED THROUGH TESTING. DISSECTION SHOWED A LEAKING HAEMOSTATIC VALVE.

    Description of Event or Problem · 1

    A CRYOABLATION PROCEDURE WAS PERFORMED USING THE ARCTIC FRONT CATHETER AND THE FLEXCATH STEERABLE SHEATH (CATHETER INTRODUCER). WHILE ASPIRATING AND FLUSHING THE SHEATH, THE PHYSICIAN REPORTED THAT AIR WAS COMING IN FROM THE SIDE PORT OF THE FLEXCATH STEERABLE SHEATH. THE PROCEDURE WAS STOPPED. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH DRA MEDTRONIC CRYOCATH LP 3FC12 23511

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR