BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLIPPER MREYE DETACHABLE EMBOLIZATION COIL

    MDR report key: 9004113 · Received September 12, 2019

    Report

    Report Number
    3002808486-2019-01468
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Date of Event
    June 27, 2019
    Report Date
    June 23, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002483552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# PR271080. INVESTIGATION CONCLUDED THAT THE EVENT COULD NOT LEAD TO A SEROIUS INJURY. THEREFORE THIS EVENT IS CONSIDERED NOT REPORTABLE IN US. SUMMARY OF INVESTIGATIONAL FINDINGS: COILS WOULD NOT RETRACT INTO DELIVERY SYSTEM FOR REPOSITION, COILS AND DELIVERY SYSTEM WAS REMOVED. NO HARM REPORTED, BUT PROLONGED PROCEDURE TIME. A PRODUCT EVALUATION OF THE RETURNED COIL AND DELIVERY WIRE REVEALED NO NONCONFORMANCE¿S ON THE COIL. BASED ON THE INFORMATION MADE AVAILABLE TO US, IT IS UNKNOWN WHY THE COIL COULD NOT BE REDRAWN INTO THE UNKNOWN CATHETER, BUT E.G. AN INCOMPATIBLE CATHETER OR CLOT FORMATION ON THE COIL FIBERS, PROLONGED EXPOSURE TO THE BLOOD SYSTEM MAY MAKE COIL RETRIEVAL DIFFICULT. PRECAUTIONS IN THE IFU STATES: IT IS IMPORTANT TO FOLLOW THE LOADING PROCEDURE CAREFULLY IN ORDER TO AVOID COMPLICATIONS DURING ATTACHMENT AND DETACHMENT OF THE COIL. ENSURE THAT THE STRAIGHTENING MANDRIL IS AT THE TIP OF THE COIL DURING ADVANCEMENT THROUGH THE CATHETER; IF NOT, THE COIL MAY START COILING UP INSIDE THE CATHETER, WHICH MAY COMPLICATE DETACHMENT. IF, AT ANY TIME DURING THE PROCEDURE (ADVANCEMENT OR DETACHMENT), RESISTANCE IS FELT, DO NOT ATTEMPT TO USE FORCE TO OVERCOME THE PROBLEM; REMOVE AND REPLACE THE WHOLE SYSTEM IF NECESSARY. INSTRUCTIONS FOR USE - COIL DEPLOYMENT IN THE IFU STATES: NOTE: BEFORE PERFORMING THE FOLLOWING STEPS, ENSURE THAT THE LOADING PROCEDURE DESCRIBED ABOVE HAS BEEN SUCCESSFULLY COMPLETED. IF THE DETACHABLE EMBOLIZATION COIL POSITION IS UNSATISFACTORY, PULL THE COIL BACK INTO THE CATHETER. DUE TO CLOT FORMATION ON THE COIL FIBERS, PROLONGED EXPOSURE TO THE BLOOD SYSTEM MAY MAKE COIL RETRIEVAL DIFFICULT. IT IS RECOMMENDED TO EXCHANGE TO A NEW EMBOLIZATION COIL BEFORE CONTINUING WITH THE PROCEDURE. THE DELIVERY WIRE MAY BE USED FOR MULTIPLE COIL PLACEMENTS WITHIN A SINGLE PROCEDURE. INSPECT THE DELIVERY WIRE PRIOR TO RE-USE TO ENSURE THAT IT HAS NOT BEEN DAMAGED DURING ITS INITIAL USE. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT WAS DETERMINED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE FINAL RELEASE, THERE IS OBJECTIVE EVIDENCE THAT THE DEVICE HISTORY RECORD WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). OCCUPATION: ADMINISTRATIVE SECRETARY. SIMILAR TO DEVICE UNDER PMA/510(K) K150964. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER. IT WAS A PEDS CASE WITH A (B)(6) GIRL. THE PROCEDURE WAS FOR A PDA OCCLUDE. A BALLOON EDGE CATHETER, 5FR 60 CM DOUBLE LUMEN, WAS USED ALONG WITH AN .014 180CM WISDOM WIRE. THE DOCTOR USED ANOTHER COIL AND THE PROCEDURE WAS SUCCESSFUL. THERE WERE NO ADDITIONAL PROCEDURES NEEDED BECAUSE OF THE COIL AND NO ADVERSE EFFECTS LATER." ADDITIONAL INFORMATION RECEIVED 23AUG2019: ¿COILS RETRACTED TO REPOSITION, COILS WOULD NOT RETRACT INTO DELIVERY SYSTEM, COILS AND DELIVERY SYSTEM REMOVED, DIFFERENT OCCLUDE USED.¿ PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801980 FLIPPER MREYE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE G48355 E3755771 00827002483552

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR