BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2822377 · Received November 7, 2012

    Report

    Report Number
    3002648230-2012-00104
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SHEATH WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. VISUAL INSPECTION SHOWED THAT THE SHEATH WAS INTACT WITH NO APPARENT ISSUES. THE REPORTED ISSUE HAVE BEEN CONFIRMED THROUGH TESTING; THE LEAK WAS REPRODUCED WHEN A CATHETER WAS INTRODUCED THROUGH THE SHEATH. DISSECTION SHOWED THE HEMOSTATIC VALVE WAS LEAKING; VALVE WAS TORN. A FIELD ACTION WAS INITIATED IN JULY 2011 TO COMMUNICATE TO PHYSICIANS AND REGULATORY AUTHORITIES THIS POTENTIAL LEAK IN HEMOSTATIC VALVE OF MEDTRONIC CRYOCATH FLEXCATH 12 STEERABLE SHEATHS.

    Description of Event or Problem · 1

    AFTER THE CATHETER WAS INSERTED INTO THE SHEATH, THE PHYSICIAN WAS UNABLE TO ASPIRATE AND FLUSH THE SHEATH WITHOUT PULLING BACK AIR. THE CATHETER WAS REINSERTED THREE TIMES, BUT CONTINUED TO ASPIRATE AIR. THE SHEATH AND THE CATHETER WERE REPLACED AND THE CASE WAS COMPLETED. NO ADVERSE EVENT OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1