BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2193204 · Received August 5, 2011

    Report

    Report Number
    3002648230-2011-00118
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 HEMOSTATIC VALVE. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. RESULTS OF EVALUATION OF RETURNED DEVICE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE FLEXCATH STEERABLE SHEATH WAS PLACED IN THE PATIENT AND THE ARCTIC FRONT CATHETER WAS INSERTED INTO THE SHEATH. ON SLOW ASPIRATION, A CONTINUOUS DRAW OF AIR WAS ASPIRATED. A TOTAL OF APPROXIMATELY 40 CC OF AIR WAS ASPIRATED. THE SHEATH WAS REPLACED AND 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 35329

    Patients

    Seq Age Sex Outcome Treatment
    1