BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 6344878 · Received February 21, 2017

    Report

    Report Number
    3002808486-2017-00521
    Event Type
    Injury
    Date Received
    February 21, 2017
    Date of Event
    March 24, 2016
    Report Date
    March 24, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002202320
    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: BASED ON A VERY CONTRADICTORY DESCRIPTION PROVIDED IN THE EVENT DESCRIPTION, IT IS NOT POSSIBLE TO UNDERSTAND WHAT THE PHYSICIAN EXPERIENCED WHY THE CAUSE FOR THE EVENTS CAN NOT BE DETERMINED. THE CONTRADICTORIES TO BE MENTIONED IS WHETHER THE PHYSICIAN REACHED THE PLANNED AREA OR NOT, AS THE EVENT DESCRIPTION STATE BOTH SCENARIOS. ALONG WITH THIS, IT IS ALSO STATED THAT THE COIL DID ATTACH AND THE COIL DID NOT DETACH. THE RETURNED PRODUCT INVESTIGATION DID NOT RESULT IN ANY CLARITY TO CONFIRM THE REPORTED DIFFICULTIES. HOWEVER, A KINKED STRAIGHTENING MANDRILL WILL COMPLICATE THE PROCEDURE, AS IT IS OF OUTERMOST IMPORTANCE FOR THE STRAIGHTENING MANDRILL TO BE AT THE TIP OF THE COIL OR THE COIL MIGHT START COILING UP. IFU STATES WHICH CATHETER IS RECOMMENDED FOR THE PROCEDURE AND HOW TO LOAD THE COIL ONTO THE DELIVERY WIRE WITH THE STRAIGHTENING MANDRILL AT THE TIP OF THE COIL. PLAUSIBLY THE ENCOUNTERED PREMATURE DEPLOYMENT OF THE COIL HAS OCCURRED DUE TO UNINTENTIONALLY ROTATING THE DELIVERY WIRE COUNTERCLOCKWISE DURING INSERTION OF THE COIL, OR TOO LARGE A GAP BETWEEN THE THREAD OF THE DELIVERY WIRE AND THE COIL DURING LOADING PROCEDURE. IN CONNECTION TO THE LATELY INFORMATION PROVIDED, THERE IS ADDED A FEW COMMENTS TO THE PREVIOUS INVESTIGATION: PLAUSIBLY THE COIL MIGHT, "MOVE OVER FROM DESIRED AREA WHILE MANIPULATION OF THE RELEASING THE COIL", IF THE COIL IS NOT MINIMUM TWICE THE SIZE OF THE MINIMUM PDA DIAMETER. FOR PRECISE SIZING OF THE COIL, AN ANGIOGRAM MUST BE PERFORMED BEFORE THE PROCEDURE, FOR MEASURING LENGTH AND DIAMETER OF THE PDA. FURTHERMORE, THE COIL MIGHT DETACH INADVERTENTLY FROM THE DELIVERY WIRE IF UNINTENDED ROTATION HAS BEEN PERFORMED DURING INSERTION OF THE COIL, OR IF LOADING OF THE COIL HAS NOT BEEN IN ACCORDANCE WITH WHAT IS STATED IN THE IFU. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A (B)(6) PATIENT UNDERWENT COIL EMBOLIZATION. THE PHYSICIAN ADVANCED THE COIL TO DETERMINE THE PLACE, HOWEVER SINCE IT WAS NOT SUITABLE LOCATION, SHE ATTEMPTED TO RETRIEVE THE COIL ONCE, HOWEVER THE COIL WAS DETACHED DESPITE SHE DID NOT PERFORM THE PROCEDURE TO DETACH THE COIL, AND THE COIL REMAINED IN THE PATIENT'S BODY. THEREFORE, HE USED FORCEPS BIOPSY AND SNARE TO RETRIEVE THE COIL, BUT HE COULD NOT RETRIEVE. THE COIL WAS RETRIEVED FROM THE PATIENT'S BODY BY EMERGENCY SURGERY. ADDITIONAL INFORMATION RECEIVED 25MAR2016: A (B)(6) PATIENT UNDERWENT COIL EMBOLIZATION FROM FA. THE PHYSICIAN ADVANCED THE COIL TO PDA, HOWEVER, SINCE IT WAS NOT SUITABLE LOCATION, SHE ATTEMPTED TO RETRIEVE THE COIL ONCE. USUALLY, THE COIL IS DRAGGED INTO THE CATHETER TO COLLECT FROM THE PATIENTS¿ BODY, BUT IT COULD NOT BE DRAGGED THE COIL INTO THE CATHETER THIS TIME. THEREFORE, HE REMOVED THE COIL WITHOUT DRUGGING INTO THE CATHETER, THEN THE COIL HAD DETACHED FROM THE CATHETER NEAR FA AND IT WAS REMAINED IN THE PATIENTS¿ BODY. THEREFORE, HE USED FORCEPS BIOPSY AND SNARE TO RETRIEVE THE COIL, BUT HE COULD NOT RETRIEVE. THE COIL WAS RETRIEVED FROM THE PATIENT'S BODY BY EMERGENCY SURGERY. FORTUNATELY, THE COIL DETACHED NEAR FA (NOT THORAX AREA), AND NO ADVERSE EFFECT TO THE PATIENT REPORTED. ADDITIONAL INFORMATION RECEIVED 12APR2016: A (B)(6) PATIENT UNDERWENT COIL EMBOLIZATION FROM FA. THE PHYSICIAN ADVANCED THE COIL TO PDA. AFTER HE DETERMINED EMBOLIZATION AREA, HE STARTED RELEASING THE COIL AS HE TURNED THE PIN VICE ABOUT 2.5 TURN, HOWEVER, THE COIL WAS MOVED OVER FROM DESIRED AREA WHILE MANIPULATION OF THE RELEASING THE COIL. SO, HE DECIDE TO RETRIEVE THE COIL. SINCE IT WAS MIDDLE OF PROCEDURE OF RELEASING THE COIL, HE TRIED TO REATTACH THE COIL TO THE THREAD OF DELIVERY WIRE, HOWEVER IT COULD NOT. USUALLY, THE COIL IS DRAGGED INTO THE CATHETER TO COLLECT FROM THE PATIENTS¿ BODY, BUT IT COULD NOT BE DRAGGED THE COIL INTO THE CATHETER THIS TIME. THEREFORE, HE REMOVED THE COIL WITHOUT DRUGGING INTO THE CATHETER, THEN THE COIL HAD DETACHED FROM THE CATHETER NEAR FA AND IT WAS REMAINED IN THE PATIENTS¿ BODY. THEREFORE, HE USED FORCEPS BIOPSY AND SNARE TO RETRIEVE THE COIL, BUT HE COULD NOT RETRIEVE. THE COIL WAS RETRIEVED FROM THE PATIENT'S BODY BY EMERGENCY SURGERY. FORTUNATELY, THE COIL DETACHED NEAR FA (NOT THORAX AREA), AND NO ADVERSE EFFECT TO THE PATIENT REPORTED. ADDITIONAL INFORMATION RECEIVED FROM (B)(6) 25APR2016: COMBINED DEVICE INFORMATION WAS PROVIDED: TERUMO JUDKINS (LEFT) 3.5 (5FR) ON (B)(6) 2016: IMWCE-3-PDA4 WAS CHOSEN FOR EMBOLIZATION OF PDA (SMALLEST DIAMETER 0.4MM). DELIVERY WIRE WAS ATTACHED TO THE COIL, AND THOSE DEVICE WERE ADVANCED FROM ARTERY SIDE OF PDA. ONE LOOP OF THE COIL WAS PLACED AT PULMONARY ARTERY SIDE, AND THREE LOOPS WERE PLACED AT AORTA SIDE, THEN, THE PHYSICIAN ATTEMPTED TO DETACH THE COIL BY TURNING THE LOADING CARTRIDGE COUNTERCLOCKWISE. HOWEVER, THE COIL WOULD NOT DETACH. WHEN HE ATTEMPTED TO TURN MORE TO DETACH THE COIL, ONE LOOP OF THE COIL AT PULMONARY ARTERY FELL INTO AORTA SIDE. (ALL LOOPS FALL INTO AORTA SIDE WITHOUT COIL DETACHMENT.) SO, THE PHYSICIAN PULLED THE DELIVERY WIRE TO ATTRACT THE COIL INTO 4FR SHEATH WHICH WAS PLACED RIGHT FA TO RETRIEVE THE COIL, BUT IT WOULD NOT ATTRACTED. THEN, HE PULLED SHEATH AND DELIVERY WIRE TOGETHER TO RETRIEVE, SO, THE DELIVERY WIRE AND SHEATH COULD BE RETRIEVE FROM THE PATIENTS¿ BODY, BUT THE COIL REMAINED IN RIGHT FA. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL FROM LEFT FA USING SNARE AND BIOPSY FORCEPS, HOWEVER IT WAS FAILED BECAUSE FA ITSELF WAS THIN. HE GAVE UP TO RETRIEVE THE COIL USING CATHETER, THEREFORE, HE INCISED RIGHT FA TO RETRIEVE THE COIL UNDER GENERAL ANESTHESIA. AFTER OPERATION, IT WAS CONFIRMED THAT THE BLOOD FLOW OF RIGHT FA WAS FINE BY ANGIOGRAPHY. PATIENT OUTCOME: NO ADVERSE EFFECT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128505 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002202320

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention