BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 8694794 · Received June 13, 2019

    Report

    Report Number
    3002808486-2019-00733
    Event Type
    Injury
    Date Received
    June 13, 2019
    Date of Event
    May 17, 2019
    Report Date
    December 10, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002202313
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). AFTER INVESTIGATION THE EVENT FOR THIS PR# IS NO LONGER REPORTABLE AS IT IS NOT RELATED TO THE COIL, BUT TO THE DELIVERY WIRE, WHICH IS HANDLED IN (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: DURING THE PROCEDURE THE COIL WAS DEPLOYED WITH A SHORT SECTION OF THE DELIVERY WIRE STILL ATTACHED. NO HARM TO PATIENT REPORTED. NO PRODUCT RETURNED, BUT PRODUCT EVALUATION OF THE RETURNED TDS ((B)(4)) CONFIRM THAT THE THREAD ON THE TDS WAS SEPARATED AND THE MOST DISTAL PART WAS MISSING. IT IS UNKNOWN HOW AND WHY THESE DAMAGES OCCURRED, BUT TOO MANY TURNS/ROTATIONS DURING DEPLOYMENT HAS PREVIOUSLY CAUSED SIMILAR DAMAGE OF THREAD. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOT WORKING AS INTENDED. 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.

    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)PMA K150964. INVESTIGATION IS STILL IN PROGRESS. 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING THE PROCEDURE THE IMWCE-3-PDA3 ((B)(4)) COIL WAS DEPLOYED WITH A SHORT SECTION OF THE DELIVERY WIRE STILL ATTACHED (TDS-110-PDS) ((B)(4)). PATIENT OUTCOME: A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY; PART OF THE DELIVERY WIRE, WHICH WAS NOT RETRIEVED. 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
    488741 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE E3766354 00827002202313

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening