BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 6360048 · Received February 27, 2017

    Report

    Report Number
    3002808486-2017-00656
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002202351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) K063619. MFR DATE UNKNOWN AS LOT # IS UNKNOWN. SUMMARY OF INVESTIGATIONAL FINDINGS: EXAMINATION OF RETURNED DEVICES FOUND LARGE AMOUNT OF BLOOD INSIDE THE INTRODUCER AND GUIDING CATHETER, WHY THE GUIDE WIRE WAS STICKING IN THE INTRODUCER AND INSIDE THE CATHETER. THE GUIDE WIRE WAS CURVED AND SEVERAL BENDS WERE OBSERVED. USED GUIDING CATHETER WAS A 4 FR. CORDIS MPS CATHETER WHICH WAS FOUND TWISTED AND SEPARATED. IT WAS NOT POSSIBLE TO DETERMINE THE EXACT INNER LUMEN, BUT IT WAS MEASURED TO BE ABOUT 0.40 INCHES. TWO JDS COIL DELIVERY WIRES WERE RETURNED, ONE WITH THE JACKSON COIL THE PHYSICIAN DECIDED NOT TO USE. EXAMINATION OF THE WIRE AND COIL FOUND NO ISSUES. THE SIZE OF THE COIL WAS MEASURED TO BE 4 MM AND BLOOD WAS FOUND ON THE FIBRES. THREAD ON THE SECOND DELIVERY WIRE WAS EXTENDED AND BLOOD WAS FOUND ON IT. THE USED COIL WAS NOT RETURNED, AS STATED " IT BROKE IN PIECES". BASED ON THE FINDINGS AND THE INFORMATION PROVIDED IN THE DESCRIPTION OF EVENT, IT IS LIKELY THAT COIL DETACHMENT COULD NOT BE PERFORMED DUE TO HIGH RESISTANCE RELATED TO BLOOD CLOTTED INSIDE THE CATHETER AND INTRODUCER. SINCE THE EXACT SIZE OF USED GUIDING CATHETER CANNOT BE DETERMINED, IT IS UNKNOWN IF THE EVENT IS RELATED TO IT. HOWEVER, THE 4 FR. GUIDING CATHETER IS NOT AS STABLE AS THE RECOMMENDED 5 FR., WHY IT PLAUSIBLY TWISTED AND SEPARATED DUE TO HIGH RESISTANCE DURING THE LOADING PROCEDURE. JDS AND JACKSON COIL IS INTENDED FOR ARTERIAL AND VENOUS EMBOLIZATION. PDA COIL WITH TDS IS INTENDED FOR PATENT DUCTUS ARTERIOSUS CLOSURE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE COIL DID NOT COME OFF. IT WAS NOT POSSIBLE TO DEPLOY THE COIL. THEY HAD AT FIRST USED A JACKSON COIL WITH THE JDS. THE JACKSON WASN'T FIT AND THEY DECIDED TO USE A IMWCE-5-PDA4. THEY SCREWED THE FLIPPER ON THE SCREW FROM THE JACKSON COIL. IT WASN'T POSSIBLE TO DEPLOY THE COIL. AND WHILE THE REMOVING FROM THE COIL IT BROKE IN PIECES. 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
    145681 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002202351

    Patients

    Seq Age Sex Outcome Treatment
    1