BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2192441 · Received August 5, 2011

    Report

    Report Number
    3002648230-2011-00115
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 (B)(4) 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

    DURING A CRYOABLATION PROCEDURE, AFTER THE REMOVAL OF A MAPPING CATHETER FROM THE FLEXCATH STEERABLE SHEATH AND THE INTRODUCTION OF THE ARCTIC FRONT CATHETER, AIR WAS ASPIRATED INTO THE SHEATH. THE FLEXCATH STEERABLE 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 38075

    Patients

    Seq Age Sex Outcome Treatment
    1