BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 6363467 · Received February 28, 2017

    Report

    Report Number
    3002808486-2017-00655
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    September 25, 2012
    Report Date
    September 26, 2012
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002202337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) K063619. SUMMARY OF INVESTIGATIONAL FINDINGS: INSPECTION OF THE RETURNED DELIVERY SYSTEM SHOWS THE THREAD IS MISSING. THE REMAINING THREAD PORTION IS SORT OF TURNED TOWARDS THE CENTER OF THE DELIVERY SYSTEM, LIKE THE DELIVERY SYSTEM HAS BEEN TURNED CLOCKWISE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICE WAS NOT MANUFACTURED PER SPECIFICATION. BLOOD IS NOTED ON THE ENTIRE LENGTH OF THE DELIVERY SYSTEM. THE STRAIGHTENING MANDRILL STUCK INSIDE THE DELIVERY SYSTEM PARTLY DUE TO COAGULATED BLOOD AND THE DAMAGED THREAD, THUS BLOCKING THE INNER LUMEN OF THE DELIVERY SYSTEM. ONLY AN UNUSED PINVISE IS RETURNED WITH THE SYSTEM. ACCORDING TO THE EVENT DESCRIPTION THE PHYSICIAN USED A PINVISE. HOWEVER, IT IS NOT RETURNED TO AID THE INVESTIGATION. THE PHYSICIAN HAS NOT INFORMED, WHICH TYPE OF CATHETER WAS USED DURING THE PROCEDURE. THE LUMEN SHOULD BE AT LEAST 0.41 INCHES. IT IS BELIEVED THAT USER ERROR CAUSED/CONTRIBUTED TO THE FAILURE MODE THE RISK OF DETACH DIFFICULTIES IS ADDRESSED IN THE IFU. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THERE WAS NO PROBLEM IN THE PATIENT'S ANATOMY AND THE DEVICE WAS USED FOR PATENT DUCTUS ARTERIOSUS. IMWCE-6.5-PDA5 WAS PLACED AS THE FIRST COIL SUCCESSFULLY, AND THE COMPLAINT DEVICE WAS THE SECOND COIL IN THE PROCEDURE. THOUGH THE PHYSICIAN TURNED THE PIN VISE TO DETACH THE COIL, IT COULD NOT BE DETACHED. WHEN HE TURNED THE PIN VISE SEVERAL TIMES ADDITIONALLY, A TIP OF THE THREAD OF DELIVERY WIRE SEPARATED FROM THE DELIVERY SYSTEM, AND THE COIL WAS DETACHED. THE COIL AND THE SEPARATED SEGMENT OF THE TREAD OF DELIVERY WIRE WENT INTO THE DUCTUS ARTERIOSIS AND EMBOLISED THE BLOOD FLOW EVENTUALLY. NO ADDITIONAL TREATMENT WAS CONDUCTED AND THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME: THERE HAS BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147403 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002202337

    Patients

    Seq Age Sex Outcome Treatment
    1