BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR SYSTEM

    MDR report key: 2527425 · Received April 6, 2012

    Report

    Report Number
    3001627457-2012-00002
    Event Type
    Malfunction
    Date Received
    April 6, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 6, 2012
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K081467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL # 30 CM. INVESTIGATION SUMMARY: INSPECTION OF THE RETURNED CATHETER CONFIRMED THE MARKER BANDS HAS BEEN PROPERLY SWAGED ONTO THE CATHETER DURING MANUFACTURE. THE PINCH MARKS LEFT BY THE SWAGED BANDS WERE CLEARLY VISIBLE. THE USER REPORTED USING THE DEVICE WITH AN INTRODUCER SHEATH THAT HAD A TOUGHY-BORST TYPE ROTATING HEMOSTASIS VALVE. THE CONDITION OF THE DEVICE WAS CONSISTENT WITH HAVING BEEN WITHDRAWN THROUGH THE ROTATING HEMOSTASIS VALVE BEFORE IT HAD BEEN ADEQUATELY LOOSENED RESULTING IN REMOVAL OF THE MARKER BANDS. BECAUSE THE MARKER BANDS WERE NOT VISIBLE ON XRAYS TAKEN OF THE PT, IT IS MOST LIKELY THAT THEY REMAINED INSIDE THE INTRODUCER SHEATH AND WERE REMOVED AND DISPOSED OF WITH THE SHEATH.

    Description of Event or Problem · 1

    DURING TREATMENT OF THE PT, THE DEVICE ALARMED AND TURNED OFF. THE DEVICE WAS RETURNED TO EKOS FOR INVESTIGATION AND UPON INSPECTION, THE PLATINUM MARKER BANDS WERE NO LONGER ON THE IDDC. NO COMPLICATIONS OR ADVERSE EVENTS WERE REPORTED. UPON DETERMINING THE MARKER BANDS WERE MISSING, THE USER FACILITY WAS NOTIFIED. THE PT WAS NOTIFIED AND AGREED TO X-RAYS LOOKING FOR THE MARKER BANDS. THE MARKER BANDS WERE NOT FOUND IN THE PT. BECAUSE THE LOSS OF THE DEVICE AT EKOS AND BECAUSE THE MARKER BANDS WERE NOT LOCATED INSIDE THE PT, IT WAS NOT POSSIBLE TO DETERMINE WITH CERTAINTY WHEN THE MARKER BANDS WERE DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EKOSONIC ENDOVASCULAR SYSTEM CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 106CM 110524024-001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK