BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 6344650 · Received February 21, 2017

    Report

    Report Number
    3002808486-2017-00542
    Event Type
    Injury
    Date Received
    February 21, 2017
    Date of Event
    September 27, 2012
    Report Date
    November 13, 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. SUMMARY OF INVESTIGATIONAL FINDINGS: ONE USED PRODUCT RETURNED IN ORIGINAL PACKAGING. THE COIL WAS USED AND BLOOD WAS ON THE FIBERS. ONE KINK WAS OBSERVED ON THE THREAD OF THE COIL, HOWEVER IT IS ASSUMED THIS OCCURRED DURING TRANSPORTATION BACK TO MANUFACTURER. VISUAL INSPECTION FOUND NO OTHER PROBLEMS WITH THE COIL OR THE THREAD. IT IS PLAUSIBLE THAT THE COIL WAS PREMATURELY RELEASED DUE TO UNINTENTIONALLY ROTATION OF THE DELIVERY WIRE DURING PLACEMENT OF THE COIL, OR TO A LARGE GAP BETWEEN THE THREAD OF THE DELIVERY WIRE AND THE COIL DURING LOADING PROCEDURE. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHEN COIL REACHED TO THE RIGHT POSITION IN THE PATIENT'S BODY, THE COIL WAS PREMATURELY RELEASED PRIOR TO DEPLOY. THE DOCTOR USED WIRE BASKET AND OTHER TOOL TO RETRIEVE THE COIL FROM HEART. THEN CHANGE ANOTHER PRODUCT TO FINISH THE PROCEDURE. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128036 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002202368

    Patients

    Seq Age Sex Outcome Treatment
    1 1 Required Intervention