BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2123408 · Received June 14, 2011

    Report

    Report Number
    3002648230-2011-00048
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 HEMOSTATIC VALVE.

    Description of Event or Problem · 1

    DURING A CRYOABLATION PROCEDURE PERFORMED IN GERMANY, THE ARCTIC FRONT CATHETER WAS INSERTED IN THE FLEXCATH STEERABLE SHEATH (CATHETER INTRODUCER) AND PLACED INTO THE LEFT ATRIUM. WHEN ASPIRATING THE SHEATH, THE PHYSICIAN REPORTED THAT THERE WERE AIR BUBBLES PRESENT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 38077

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR