BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 8163591 · Received December 14, 2018

    Report

    Report Number
    3002808486-2018-01499
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    October 2, 2018
    Report Date
    March 22, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002202368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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). NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) (B)(4). REGISTRATION NO.: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION IS BASED ON EVENT DESCRIPTION ONLY. NO PRODUCT WAS RETURNED, NO IMAGING WAS PROVIDED. THEREFORE, IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE OCCURRED BASED ON THE LIMITED INFORMATION MADE AVAILABLE TO US, BUT E.G. INSUFFICIENT LOADING, INSUFFICIENT FLUSHING OR PROLONGED PROCEDURE TIME LEADING TO SOLIDIFICATION OF CONTRAST OR BLOOD COULD HAVE CONTRIBUTED TO THE FAILED DEPLOYMENT. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. 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 DEVICES UNDER PMA/510(K) K063619. INVESTIGATION IS STILL IN PROGRESS.

    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: "PERFORMED HYBRID PROCEDURE; INTRODUCER POSITIONED IN THE ASCENDING AORTA, CATHETERIZED SHUNT OF BLALOCK TAUSSIG TO THE LEFT, AND POSITIONED THE MREYE FLIPPER COIL AND EXPANDED INSIDE THE SHUNT. AT THE MOMENT OF RELEASING THE COIL, IT DID NOT DETACH ITSELF FROM THE SYSTEM; THERE SEEMS TO HAVE BEEN A DISTORTION IN THE RELEASE CABLE. THE COIL SYSTEM WAS COMPLETELY WITHDRAWN AND WAS CHOSEN TO ATTEMPT TO CLOSE THE SHUNT THROUGH THE SURGICAL SECTION." PATIENT OUTCOME: THE PATIENT REQUIRED SHUNT CLOSURE THROUGH A SURGICAL SECTION. 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
    1004255 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE E3708567 00827002202368

    Patients

    Seq Age Sex Outcome Treatment
    1