BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 6306826 · Received February 7, 2017

    Report

    Report Number
    3002808486-2017-00332
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    October 30, 2013
    Report Date
    November 1, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002202368
    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: COIL AND DELIVERY WIRE WERE RETURNED ASSEMBLED. DISTAL PART OF THE LOADING CARTRIDGE WAS RETURNED TO AID THE INVESTIGATION. INSPECTION OF THE LOADING CARTRIDGE CONFIRMED COMPLAINT SINCE THE TIP WAS DEFORMED. MANUFACTURING WAS INFORMED OF THIS EVENT AND IT WAS NOT POSSIBLE TO DETERMINE ROOT CAUSE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: COIL EMBOLIZATION OF PATENT DUCTUS ARTERIOSUS WAS PLANNED. THE DELIVERY WIRE WAS LOADED WITH THE COIL AND THE COIL LOADING CARTRIDGE WAS INTRODUCED INTO THE HUB OF THE CATHETER. THEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE COIL DELIVERY SYSTEM AS INSTRUCTED IN THE IFU. HOWEVER, THE DISTAL END OF THE LOADING CARTRIDGE WAS OCCLUDED. HE ATTEMPTED TO ADVANCE THE DELIVERY SYSTEM BY CUTTING THE DISTAL TIP OF THE LOADING CARTRIDGE BUT THE COIL GOT CAUGHT ON THE CUT AND THE DELIVERY SYSTEM BECAME KINKED. ANOTHER DEVICE OF THE SAME RPN WAS USED INSTEAD FOR THE PROCEDURE. PATIENT OUTCOME: PATIENT HAD A FAVORABLE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91181 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002202368

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO