BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 3172571 · Received June 17, 2013

    Report

    Report Number
    3002648230-2013-00094
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. VISUAL INSPECTION SHOWED THE SHAFT WAS INTACT WITH NO APPARENT ISSUES. THE REPORTED LEAK FROM THE HEMOSTATIC VALVE COULD NOT BE REPRODUCED. MULTIPLE ASPIRATIONS / INJECTIONS WERE PERFORMED WITHOUT AIR BUBBLES OR LEAKS; HEMOSTATIC VALVE WAS LEAK TIGHT. THIS REPORT WILL BE RECORDED AND TRENDED.

    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 HEMOSTATIC VALVE OF THE SHEATH. THE CRYOABLATION PROCEDURE WAS COMPLETED WITHOUT CHANGING THE SHEATH. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274018 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 51206

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR