BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 6344663 · Received February 21, 2017

    Report

    Report Number
    3002808486-2017-00539
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    May 31, 2013
    Report Date
    June 5, 2013
    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: DEVICE WAS NOT RETURNED WHY INVESTIGATION WILL ONLY BE BASED ON DESCRIPTION OF EVENT. BASED ON WHAT IS REPORTED IT IS LIKELY THAT THE COIL WAS DAMAGED DURING THE MANIPULATION INSIDE CATHETER AND WHEN REMOVED FROM THE PATIENT. BECAUSE THE COIL MAY HAVE BEEN DAMAGED DURING SECOND ATTEMPT OF INSERTION THIS MAY HAVE BEEN THE REASON FOR EARLY DETACHMENT. IT IS UNCLEAR WHY THE PHYSICIAN USED THE COIL AFTER DETERMINED THE SIZE WAS TO SMALL. ADDITIONALLY THE IFU STATES THAT IF DIFFICULTIES OCCUR WHEN DETACHING THE EMBOLIZATION COIL, OR IF RESISTANCE IS FELT WITHDRAWING THE DELIVERY WIRE THE SYSTEM SHOULD BE PERFORMED TOGETHER WITH THE GUIDING CATHETER AND REPLACED BY A NEW SYSTEM. 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: THE PHYSICIAN INSERTED A 5 FR OF TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER FROM THE RIGHT FEMORAL AND HAD IT PASSED THE DUCTUS ARTERIOSIS AND PLACED THERE. THEN HE INSERTED MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL AND HAD 1 LOOP OF THE COIL OUT OF THE CATHETER TIP IN THE LUNG ARTERY SIDE. THEN HE ATTEMPTED TO PULLED THE WIRE AND THE CATHETER BUT THE COIL WAS PULLED TO THE AORTA. HE DETERMINED THE COIL WAS TOO SMALL AND REMOVED IT OUTSIDE OF THE PATIENT'S BODY ONCE. HOWEVER HE INSERTED IT AGAIN AND HAD 1 LOOP OF THE COIL OUT OF THE CATHETER TIP AGAIN. THEN HE PULLED THE WIRE AND THE CATHETER BUT THE REST OF THE LOOPS DID NOT FORM. SO HE PUSHED AND PULLED THE DELIVERY SYSTEM AND THE CATHETER, AND HE FOUND THE COIL WAS DETACHED IN THE CATHETER AT APPROX. 1 CM FROM THE TIP. THE COIL WAS REMOVED SUCCESSFULLY WITH A GOOSE NECK SNARE WITH ANOTHER PHYSICIAN'S HELP. HE USED ANOTHER PDA CLOSURE DETACHABLE EMBOLIZATION COIL WITH THE DIFFERENT LOT TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128190 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002202337

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention