BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 6850987 · Received September 8, 2017

    Report

    Report Number
    3002808486-2017-01771
    Event Type
    Injury
    Date Received
    September 8, 2017
    Date of Event
    August 18, 2017
    Report Date
    August 18, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER 510(K) K063619. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: FIRST COIL/TDS ((B)(4)): ANOTHER MANUFACTURER'S ANGIO CATHETER (4.2FR WITH 0.041" INNER LUMEN/ BY GOODMAN) WAS INSERTED FROM THE RIGHT GROIN FIRST. THEN, CONNECTED IMWCE-5-PDA5 ((B)(4)) AND TDS-110-PDA ((B)(4)) WERE ADVANCED THROUGH THE CATHETER TO THE AORTIC ARCH. THE COIL WAS PROTRUDED 1.5 LOOP IN THE PA FROM THE PDA, THEN THE PHYSICIAN WITHDREW THE COIL BACK INTO THE CATHETER IN ORDER TO CHANGE THE COIL POSITION INSIDE THE PA. HOWEVER, IT COULD NOT BE WITHDRAWN BUT THE COIL WAS UNRAVELED. THEN, THE ANGIO CATHETER WITH THE DETACHED COIL WAS REMOVED FROM THE PATIENT. IT WAS NOTED THAT THE CONNECTION BETWEEN THE WIRE AND COIL/ THREADS WERE UNRAVELED/DEFORMED WHEN THE DEVICES WERE REMOVED. THEN, THE DEVICES WERE CHANGED TO THE SECOND DEVICES. ADDITIONAL INFORMATION RECEIVED 22AUG2017: SECOND COIL ((B)(4)): A YOUNG PHYSICIAN TURNED THE PIN-VISE CLOCKWISE BY ERROR, THEN THE COIL UNRAVELED AND DEFORMED. THEN, THE DEVICES WERE CHANGED TO THE THIRD ONE. THIRD COIL ((B)(4)): SINCE THE THREADS OF THE COIL AND TDS WERE NOT PROPERLY CONNECTED, THE COIL GOT DETACHED ACCIDENTALLY WHEN THE HANDLE OF STRAIGHTENING MANDRIL WAS WITHDRAWN PRIOR TO AN ATTEMPT OF COIL DETACHMENT, THEN THE COIL WENT INTO THE DISTAL SITE OF THE PA. A SNARE DEVICE WAS APPROACHED FROM THE VEIN AND IT RETRIEVED THE COIL FROM THE PA. TDS USED WITH THE SECOND AND THIRD COIL: TDS-110-PDA/ LOT# E3589766. PATIENT OUTCOME: THE PROCEDURE WAS FINISHED WITH NO FURTHER TREATMENT ON THE DAY SINCE THE DEVICE STOCK RAN OUT. HOWEVER, IT IS SCHEDULED TO BE PERFORMED ON A DIFFERENT DAY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: ONLY THE FIRST COIL AND THE FIRST TDS USED DURING THE PROCEDURE ARE RETURNED FOR INVESTIGATION. COIL IS STILL ATTACHED TO THE TDS WIRE, BUT ONLY WITH ABOUT ONE WINDING. THE COIL CAN BE DETACHED. IT IS NOT POSSIBLE TO MOVE THE MANDRIL, NEITHER BEFORE NOR AFTER DETACHMENT OF THE COIL. IT MUST HAVE BEEN POSSIBLE AT CUSTOMER SITE AS IT IS FOUND TO HAVE BEEN ADVANCED INSIDE THE COIL. IT IS PERHAPS DUE TO SOLIDIFIED BLOOD INSIDE THE SYSTEM. IT LOOKS LIKE COIL WAS ELONGATED WHEN IT WAS ONLY SLIGHTLY ATTACHED TO THE TDS, NOT WHEN BEING COMPLETELY ATTACHED. NOTHING INDICATES PRODUCTS WERE MANUFACTURED OUT OF SPECIFICATIONS. THE GOODMAN CATHETER USED IS STATED TO HAVE AN INNER DIAMETER OF 0.041 INCH AND SHOULD THEREFORE BE APPROPRIATE FOR THE USE WITH THE COOK IMWCE AND TDS. IT IS STATED THAT THE COIL WAS RETRACTED IN AN ATTEMPT TO REPOSITION IT, BUT AT INVESTIGATION THE COIL WAS FOUND ONLY BARELY ATTACHED TO THE TDS SO DETACHMENT MIGHT HAVE BEEN ATTEMPTED BEFORE THIS. IF SO, THIS COULD HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED BY THE USER. THE EXACT REASON FOR THE COIL ELONGATION CANNOT BE DETERMINED, BUT THE MOST LIKELY ROOT CAUSE IS CONCLUDED TO BE USER TECHNIQUE. THE USE OF THE SECOND AND THIRD COIL IS STATED TO HAVE FAILED DUE TO USER ERROR. TDS AND IMWCE ARE INSPECTED DURING MANUFACTURING. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631468 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention