BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 11736672 · Received April 28, 2021

    Report

    Report Number
    3002808486-2021-01158
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    April 22, 2021
    Report Date
    August 5, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    10827002202365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE COIL DID NOT PROPERLY DETACH AND WHILE TRYING TO REMOVE IT WITH THE DELIVERY WIRE, THE COIL DETACHED IN INCORRECT POSITION AND WAS IMMEDIATELY REMOVED. COIL AS WELL AS THE DELIVERY WIRE WERE RETURNED. THE DELIVERY WIRE HAD A KINK 158MM FROM THE PROXIMAL END AND THE THREAD WAS ELONGATED AND HAD SOME COIL FIBERS ATTACHED. NO NONCONFORMANCES WERE NOTED IN THE COIL THREAD, BUT THE COIL ITSELF HAD ELONGATED AND FRACTURED. HOWEVER, AN ANALYSIS BY SCANNING ELECTRON MICROSCOPE DID NOT REVEAL ANY MATERIAL DEFECT, BUT DIRECTIONAL PLASTIC DEFORMATION SEEN IN THE FRACTURE SURFACE SUGGESTED THAT IT WAS CAUSED BY TORSION-INDUCED FAILURES, LIKELY DURING ATTEMPTS TO RETRIEVE THE DELIVERY WIRE WITH THE COILED COIL BACK INTO THE CATHETER. BASED ON THE INVESTIGATION FINDINGS AND THE INFORMATION PROVIDED THE EXACT REASON FOR THE DIFFICULTIES ENCOUNTERED WHEN ATTEMPTING TO DETACH THE COIL IN THE FIRST PLACE CANNOT BE DETERMINED, BUT ACCORDING TO INSTRUCTIONS FOR USE THE GUIDING CATHETER AND THE DELIVERY WIRE MUST BE REMOVED SIMULTANEOUSLY, IN CASE DIFFICULTIES OCCUR WHEN DETACHING THE EMBOLIZATION COIL. IT WAS ASSESSED THAT BECAUSE NO NON-CONFORMANCES WERE DETECTED, THERE IS EVIDENCE THAT THE DHR 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). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. OCCUPATION: LAB TECHNICIAN. SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K150964 . INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: COIL COULD NOT BE RETRIEVED PROPERLY. DURING EMBOLISATION OF DUCTUS ARTERIOSUS COIL DID NOT EASILY AND PROPPERLY DETATCH. WHILE TRYING TO REMOVE THE DELIVERY WIRE WITH THE COIL, THE COIL DETATCHED NOT AT RIGHT PLACE AND HAS TO BE RETRIEVED RIGHT AFTERWARDS. PATIENT OUTCOME: THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE, AS STATED IN DESCRIPTION OF EVENT. 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
    634379 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE E3634116 10827002202365

    Patients

    Seq Age Sex Outcome Treatment
    1