BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 6371126 · Received March 2, 2017

    Report

    Report Number
    3002808486-2017-00657
    Event Type
    Injury
    Date Received
    March 2, 2017
    Date of Event
    July 12, 2012
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002202368
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) K063619. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: USED DELIVERY SYSTEM AND COIL WERE RETURNED. ONE ADDITIONAL DELIVERY SYSTEM WAS RETURNED (NOT COOK MEDICAL), MANUFACTURER IS UNKNOWN. THE ADAPTER FROM THE HOLDER WAS ATTACHED TO THE COOK MEDICAL DELIVERY SYSTEM, AND IT IS BELIEVED THAT THIS DEVICE WAS USED AS PINVICE, INSTEAD OF THE ACTUAL PIN VICE, WHICH WAS NOT RETURNED. INSPECTION OF THE RETURNED COIL FOUND A LARGE PART HAD UNRAVELLED, HOWEVER NO DAMAGE WAS FOUND TO THE THREAD OF THE COIL. THREAD OF DELIVERY SYSTEM WAS FOUND UNRAVELLED AND BENT. FIBERS WERE FOUND ON THE THREAD OF THE DELIVERY SYSTEM, INDICATING THAT THE THREAD HAS BEEN IN CONTACT WITH THE DISTAL PART OF A COIL WITH FIBERS. THE THREAD IS TURNED AWAY FROM THE CENTER INDICATING PHYSICIAN TURNED THE PINVICE CLOCKWISE TO DETACH THE COIL AS INTENDED. THIS ALSO INDICATES THAT THE THREAD OF THE DELIVERY SYSTEM STUCK. SINCE FIBERS WERE FOUND ON THE THREAD IT IS POSSIBLE IT STUCK IN ANOTHER COIL. THE COIL MAY HAVE BELONGED TO THE RETURNED DELIVERY SYSTEM FROM UNKNOWN MANUFACTURER. IT IS POSSIBLE THAT THE PHYSICIAN COULD NOT RELEASE THE COIL BECAUSE THE THREAD OF THE DELIVERY SYSTEM STUCK IN THE FIBERS OF ANOTHER COIL. IT IS REPORTED IN THE COMPLAINT THAT THE DEVICE WAS USED FOR CONGENITAL HEART DISEASE, BUT NOT WHICH KIND. THE IFU STATES THAT "THE PRODUCT IS INTENDED FOR PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE". IFU ALSO STATES THAT THE" RECOMMENDED COIL DIAMETER SHOULD BE MINIMUM TWICE THE SIZE OF THE MINIMUM PDA DIAMETER". IF THIS IS FOLLOWED THE USE OF SEVERAL COILS SHOULD NOT BE NECESSARY. IT IS BELIEVED THAT USER ERROR CAUSED THE FAILURE MODE. THERE IS NO INDICATION OF THE DEVICE NOT BEING MANUFACTURED TO CURRENT SPECIFICATION, NOR TO INSUFFICIENT INFORMATION IN IFU. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING PROCEDURE, THE DELIVERY SYSTEM CAN NOT RELEASE THE FLIPPER COILS, AFTER SEVERAL TRIES, THE TIP OF DELIVERY SYSTEM WAS BROKEN AND THE COILS WAS DROPPED IN THE PATIENT BODY, THE DOCTOR RETRIEVED THE COIL BY CAPTURE FORCEPS. FINALLY, CHANGE ANOTHER FLIPPER COIL AND DELIVERY SYSTEM OF SAME TYPE TO FINISH THE PROCEDURE. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157034 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002202368

    Patients

    Seq Age Sex Outcome Treatment
    1 74 Required Intervention