BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM

    MDR report key: 6363645 · Received February 28, 2017

    Report

    Report Number
    3002808486-2017-00660
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002200265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) K063619. SUMMARY OF INVESTIGATIONAL FINDINGS: ONE PRODUCT RETURNED TO AID THE INVESTIGATION. VISUAL INSPECTION OF TDS DELIVERY WIRE SHOWED THE THREAD WAS MISSING. AS ALSO STATED IN THE DESCRIPTION OF EVENT. THE REMAINING THREAD PORTION IS TURNED TOWARDS THE CENTER OF THE DELIVERY SYSTEM, LIKE THE DELIVERY SYSTEM HAS BEEN TURNED CLOCKWISE. AS REPORTED IN DESCRIPTION OF EVENT IT IS LIKELY THAT THE COIL ENTANGLED WITH PREVIOUSLY PLACED COILS, AND COMBINED WITH INDICATED MANIPULATION "DURING COIL DELIVERY COIL WOULD NOT RELEASE", THIS MAY HAVE CAUSED THE ERROR. THE RISK OF DETACHMENT DIFFICULTIES, IS ADDRESSED IN THE IFU THERE IS NO INDICATION THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING COIL DELIVERY COIL WOULD NOT RELEASE, THE CONSULTANT HAD TO PULL BACK ON DELIVERY SYSTEM AT WHICH POINT THE COIL SNAPPED OF DELIVERY SYSTEM. ON INVESTIGATION THE CONSULTANT DECIDED THAT THIS WOULD CAUSE NO ILL EFFECTS TO PATIENT BUT WAS CONCERNED THE EVENT WAS DUE TO PRODUCT MALFUNCTION. THE CONSULTANT ADMITTED THAT THE COIL COULD POSSIBLY BEEN CAUGHT IN FIBRES FROM ANOTHER COIL WHICH WAS IMPLANTED EARLIER IN THE PROCEDURE. THIS COULD CAUSE DIFFICULTY IN DELIVERING THE COIL BUT THE CAUSE FOR CONCERN WAS THE COIL SEPARATING FROM THE DELIVERY SYSTEM. DISTAL END OF DELIVERY SYSTEM REMAINED ATTACHED TO COIL. RETRIEVAL WAS NOT ATTEMPTED AS IT WAS DECIDED THAT THIS WOULD NOT CAUSE ANY ADVERSE AFFECTS TO THE PATIENT. 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
    146852 FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002200265

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR