BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2103059 · Received May 25, 2011

    Report

    Report Number
    3002648230-2011-00031
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. IT WAS DISCARDED AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A CRYOABLATION PROCEDURE WAS PERFORMED IN (B)(6). AFTER THE ABLATION OF 3 PULMONARY VEINS, THE PHYSICIAN NOTED THAT HEPARINIZED SALINE WAS LEAKING FROM THE HAEMOSTATIC VALVE OF THE FLEXCATH STEERABLE SHEATH (CATHETER INTRODUCER). THE LEAK WAS AT THE SAME DROP RATE AS THE PRESSURIZED INFUSION (1 DROP PER SECOND). THE PHYSICIAN DECIDED TO STOP THE INFUSION AND ASPIRATE THE SHEATH TO CHECK FOR AIR. AIR APPEARED IN THE LATERAL PORT OF THE SHEATH, DESPITE THE USE OF A WET COMPRESS TO TRY AND OCCLUDE THE VALVE. BY MOVING THE CATHETER SHAFT IN THE VALVE, THE PHYSICIAN WAS ABLE TO FIND A POSITION WHERE ASPIRATION WAS POSSIBLE WITHOUT AIR INGRESS AND THE PROCEDURE WAS COMPLETED. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH DRA MEDTRONIC CRYOCATH LP 3FC12 00722

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR