BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM

    MDR report key: 6309877 · Received February 8, 2017

    Report

    Report Number
    3002808486-2017-00329
    Event Type
    Malfunction
    Date Received
    February 8, 2017
    Date of Event
    June 26, 2014
    Report Date
    July 1, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002200265
    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. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: TDS DELIVERY WIRE AND IMWCE-PDA COIL WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION FOUND TDS DELIVERY WIRE UNDAMAGED, AND SMALL AMOUNT OF BLOOD OR MEDIA WAS OBSERVED ON THE STRAIGHTENING MANDRIL IN PROXIMAL END. THE THREAD ON COIL PROTRUDED APPROXIMATELY 7 MM FROM PROXIMAL END OF COIL LOADING CARTRIDGE. FUNCTIONAL TEST WAS PERFORMED TO TEST IF THE COIL AND DELIVERY WIRE COULD CONNECT. THE STRAIGHTENING MANDRIL WAS FOUND STICKING IN FIRST ATTEMPT TO ADVANCE IT, HOWEVER LOOSENED. THE DELIVERY WIRE AND COIL CONNECTED AND NO ISSUES WERE FOUND WITH THIS PROCEDURE. BASED ON THE FINDINGS PLAUSIBLY THE ENCOUNTERED LOADING DIFFICULTIES OCCURRED IF THE STRAIGHTENING MANDRIL WAS NOT INTRODUCED INTO THE CENTER OF THE THREAD PART OF THE COIL. IF THE STRAIGHTENING MANDRIL IS NOT AT RIGHT POSITION, IT WILL LIKELY COMPLICATE THE PROCEDURE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT UNDERWENT THE EMBOLIZATION AGAINST PATENT DUCTUS ARTERIOSUS BY FEMORAL APPROACH. THE DELIVERY WIRE AND THE COIL OF THE COMPLAINT PRODUCT WERE ATTACHED TO EACH OTHER AND THEY WERE ONCE ADVANCED INTO THE CATHETER INSERTED INTO THE TARGET LESION. HOWEVER, FOR SOME REASON (DETAIL:UNKNOWN), THE DEVICE WAS RETRIEVED OUT OF THE BODY AND THE COIL DETACHED FROM THE DELIVERY WIRE SOMEHOW (DETAIL: UNKNOWN). THE PHYSICIAN ATTEMPTED TO REATTACH THE COIL TO THE DELIVERY WIRE, BUT IT COULD NOT ATTACH. ANOTHER COIL WAS USED INSTEAD WITHOUT PROBLEMS. ADDITIONAL INFORMATION RECEIVED 01JUL2014: A COIL (IMWCE-5-PDA5: (B)(4)) WAS ATTACHED TO A DELIVERY SYSTEM (TDS-110-PDA:(B)(4)) AND ADVANCED INTO THE TARGET LESION THROUGH A CATHETER. HOWEVER, WHEN APPROXIMATELY 2 LOOPS OF THE COIL WERE PROTRUDED OUT OF THE CATHETER, THE COIL ALMOST RAN OFF INTO AORTA. THEREFORE, THE PHYSICIAN DETERMINED TO CORRECT THE POSITION OF THE CATHETER. HE ATTACHED THE LOADING CARTRIDGE OF THE COIL TO THE HUB OF THE CATHETER AND WITHDREW THE COIL BACK INTO IT WITH THE COIL STILL ATTACHED TO DELIVERY SYSTEM. AFTER THE CORRECTION OF THE POSITION OF THE CATHETER, THE LOADING CARTRIDGE WAS RECONNECTED TO THE CATHETER HUB AND THE ADVANCEMENT OF THE COIL WAS TRIED, BUT THE COIL HAD BEEN SOMEHOW DETACHED FROM THE DELIVERY SYSTEM IN THE CARTRIDGE AND COULD NOT BE ADVANCED INTO THE CATHETER. THE PHYSICIAN ATTEMPTED TO REATTACH THE COIL AND DELIVERY SYSTEM, BUT IT WAS IMPOSSIBLE. THUS, BOTH OF THE DELIVERY SYSTEM AND THE COIL WERE REPLACED WITH ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94780 FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002200265

    Patients

    Seq Age Sex Outcome Treatment
    1