BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 3100378 · Received May 8, 2013

    Report

    Report Number
    3002648230-2013-00071
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THE ALLEGED FAILURE WAS NOT POSSIBLE SINCE THE DEVICE WAS NOT RETURNED; IT WAS DISCARDED BY THE USER FACILITY. THE REPORTED ISSUE IS A KNOWN ISSUE FOR THIS DEVICE AND 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WAS A LEAK FROM THE VALVE OF THE SHEATH. THE SHEATH WAS REMOVED FROM THE PATIENT AND REPLACED, AND THE CRYOABLATION PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200971 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 59056

    Patients

    Seq Age Sex Outcome Treatment
    1