BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 6359912 · Received February 27, 2017

    Report

    Report Number
    3002808486-2017-00543
    Event Type
    Injury
    Date Received
    February 27, 2017
    Date of Event
    February 7, 2013
    Report Date
    February 15, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002202368
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) K063619 (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE USED IMWCE-PDA COIL AND DELIVERY WIRE WERE RETURNED TO AID THE INVESTIGATION. VISUAL INSPECTION SHOWED THE PROXIMAL PART OF THE COIL WAS UNRAVELED. HOWEVER, NO UNRAVELING OF THE THREAD OF THE COIL WAS OBSERVED. INSPECTION OF DELIVERY WIRE FOUND THREAD COMPLETELY UNRAVELED. IT IS ASSUMED THAT COIL DETACHED UNINTENTIONALLY AND UNRAVELING OF THE DELIVERY WIRE OCCURRED AFTER DETACHMENT. THE FINDINGS INDICATE THAT EXCESSIVE FORCE WAS APPLIED TO THE DELIVERY WIRE LEADING IT TO UNRAVEL. IT IS ASSUMED THAT THE COIL UNRAVELED DURING REMOVAL FROM THE ARTERY SINCE NO UNRAVELING OF THE THREAD IS OBSERVED. UNINTENDED DETACHMENT OF THE COIL CAN OCCUR IF THE DELIVERY WIRE ACCIDENTALLY IS ROTATED COUNTER CLOCKWISE DURING INSERTION 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 SURGEON LOST THE COIL IN THE PULMONARY ARTERY: WHEN THE COIL BROKE OFF FROM THE SHEATH AND THE GUIDE. THE SPIRES WERE ABNORMALLY LENGTHENED AND DID NOT RESIST THE TRACTION. THE SURGEON RECOVERED THE COIL BY CATHETERISM WITH A LASSO. PATIENT OUTCOME: 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
    143753 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002202368

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention