BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2250049 · Received September 15, 2011

    Report

    Report Number
    3002648230-2011-00164
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 3, 2011
    Report Date
    October 5, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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. THE VISUAL INSPECTION SHOWED THAT THE SIDEPORT TUBE WAS DETACHED FROM THE HANDLE. A CAPA WAS INITIATED TO ADDRESS THIS ISSUE.

    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 SIDEPORT OF THE FLEXCATH STEERABLE SHEATH UNATTACHED FROM THE HANDLE COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 36906

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR