BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 2993220 · Received March 7, 2013

    Report

    Report Number
    3002648230-2013-00035
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. VISUAL INSPECTION SHOWED THAT THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. THE REPORTED AIR ASPIRATION WAS REPRODUCED WHEN A CATHETER WAS INTRODUCED THROUGH THE SHEATH. DISSECTION SHOWED THE HEMOSTATIC VALVE WAS LEAKING; VALVE WAS TORN. THIS REPORT WILL BE RECORDED AND TRENDED.

    Description of Event or Problem · 1

    UPON ASPIRATION OF THE SHEATH AT THE START OF THE PROCEDURE, AIR WAS CONTINUALLY BEING DRAWN BACK AND WOULD NOT RESOLVE. THE SHEATH WAS REPLACED AND THE ISSUE RESOLVED. THE PATIENT WAS STABLE THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97830 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1