BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2240684 · Received September 9, 2011

    Report

    Report Number
    3002648230-2011-00155
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE AIR ASPIRATION HAS BEEN REPRODUCED WHEN A CATHETER WAS INTRODUCED THROUGH THE SHEATH. DISSECTION SHOWED THAT THE HEMOSTATIC VALVE WAS LEAKING. 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.

    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

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

    Description of Event or Problem · 1

    DURING A CRYOABLATION PROCEDURE, THE FLEXCATH STEERABLE SHEATH WAS INSERTED IN THE LA AND ASPIRATED AND FLUSHED. THE CATHETER WAS THEN INSERTED INTO THE FLEXCATH STEERABLE SHEATH. DURING ASPIRATION, AIR WAS PRESENT IN THE FLEXCATH STEERABLE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 26512

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCTIC FRONT CATHETER 2AF282