BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM

    MDR report key: 6360049 · Received February 27, 2017

    Report

    Report Number
    3002808486-2017-00659
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    December 11, 2012
    Report Date
    December 17, 2012
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002200265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) K063619. SUMMARY OF INVESTIGATIONAL FINDINGS: USED TDS RETURNED IN ORIGINAL HOLDER AND USED IMWCE PDA COIL RETURNED IN ORIGINAL COIL LOADING CARTRIDGE. WHEN REMOVING THE WIRE FROM THE HOLDER TWO LARGE KINKS WERE OBSERVED AND IT WAS NOT POSSIBLE TO MOVE THE STRAIGHTENING MANDRIL INSIDE THE DELIVERY WIRE. FUNCTIONAL TEST WAS PERFORMED BY ATTACHING AND DETACHING THE RETURNED COIL TO THE RETURNED TDS AND NO ISSUES WITH THIS PROCEDURE WERE FOUND. IT WAS HOWEVER NOT POSSIBLE TO REMOVE THE COIL FROM THE CARTRIDGE DUE TO LARGE AMOUNT OF BLOOD ON THE COIL WHICH STUCK TO THE CARTRIDGE. IT IS STATED IN THE DESCRIPTION OF EVENT THAT THE "COIL WAS FAILED IN RELEASE DURING THE OPERATION." SINCE THE DEVICES WERE RETURNED SEPARATELY IT MUST HAVE BEEN POSSIBLE TO DETACH THE COIL WHEN THE SYSTEM WAS REMOVED FROM THE PATIENT. THEREFORE IT IS ASSUMED THAT THE DETACHMENT FAILURE IS SOLELY RELATED TO THE PROCEDURE. SINCE SEVERAL KINKS ARE OBSERVED ON THE WIRE IT IS POSSIBLE THAT THE ROOT CAUSE OF THE DETACHMENT FAILURE IS TORTUOUS ANATOMY. IF THE DELIVERY WIRE KINKS IT WILL BE HARDER TO TRANSFER THE TORQUE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: COIL WAS FAILED IN RELEASE DURING THE OPERATION. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145682 FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002200265

    Patients

    Seq Age Sex Outcome Treatment
    1 10