BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 3010283 · Received March 19, 2013

    Report

    Report Number
    3002648230-2013-00045
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE VISUAL INSPECTION SHOWED THAT THE SHAFT WAS INTACT WITH NO APPARENT ISSUES. THE REPORTED 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE PROCEDURE, FLUID WAS LEAKING OUT OF THE SHEATH'S VALVE. THE PHYSICIAN DECIDED NOT TO EXCHANGE THE SHEATH AND THE PROCEDURE WAS COMPLETED WITH THIS SHEATH. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114773 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12

    Patients

    Seq Age Sex Outcome Treatment
    1