BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 7595138 · Received June 13, 2018

    Report

    Report Number
    3002808486-2018-00673
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    May 17, 2018
    Report Date
    August 16, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002202320
    Product Problem
    Yes
    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). SIMILAR TO DEVICE UNDER 510(K) K063619. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    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. H6) EC METHOD CODE: 4109 - HISTORICAL DATA ANALYSIS. 4114 - DEVICE NOT RETURNED . EC CONCLUSION CODE: 4315 - CAUSE NOT ESTABLISHED. SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION IS BASED ON EVENT DESCRIPTION ONLY, NO PRODUCT WAS RETURNED. BASED ON THE LIMITED INFORMATION PROVIDED, IS IT NOT POSSIBLE TO DETERMINE EXACTLY WHY THE ADVANCEMENT OF THE COIL WAS UNSUCCESSFUL, BUT E.G. CATHETER KINKING, INCOMPATIBLE CATHETER, INSUFFICIENT FLUSHING, OR PROLONGED PROCEDURE TIME LEADING TO SOLIDIFICATION OF CONTRAST OR BLOOD COULD HAVE BEEN CONTRIBUTING TO THE UNSUCCESSFUL ADVANCEMENT. IT IS UNKNOWN WHICH 5 FRENCH ¿HANAKO CATHETER MULTIPURPOSE¿ THERE HAVE BEEN USED FOR THE PROCEDURE, BUT THEY ARE AVAILABLE IN BOTH 0.0395 AND 0.043 INCHES LUMEN AT THE TIP, AND ACCORDING TO IFU IS MINIMUM 0.041 INCHES REQUIRED FOR THE DEVICE. IT IS NOTICED THAT THE DEVICE WAS REPLACED WITH ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IFU: NOTE: ENSURE THAT THE STRAIGHTENING MANDRIL IS AT THE TIP OF THE COIL DURING THE PROCEDURE; IF NOT, THE COIL MIGHT START COILING UP INSIDE THE CATHETER WHICH MIGHT COMPLICATE DETACHMENT. IN ORDER TO OBTAIN STABILITY DURING COIL INTRODUCTION A 5.0 FRENCH, NON-TAPERED (NT) END HOLE ONLY MULTIPURPOSE HEART CATHETER IS RECOMMENDED. MINIMUM LUMEN .041 INCHES. NO EVIDENCE TO SUGGEST PRODUCT WAS NOT MANUFACTURED 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A CATHETER (HANAKO CATHETER MULTIPURPOSE / HANAKO MEDICAL) WAS ADVANCED THE TARGET LESION BY RIGHT FEMORAL APPROACH. THE PHYSICIAN ATTEMPTED TO ADVANCE THE IMWCE-3-PDA4 ((B)(4)) THROUGH THE CATHETER, BUT STRANGE FEELING LIKE COIL GETTING STUCK IN THE CATHETER WAS FELT ON THE WAY. THUS, THE COIL WAS EXCHANGED TO IMWCE-3-PDA4 ((B)(4)) IN CASE. HOWEVER, THIS SECOND COIL DID NOT ADVANCE THROUGH THE CATHETER SMOOTHLY EITHER, BUT FEELING OF STRANGENESS WAS FELT ONCE AGAIN. IT WAS REPLACED WITH ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME: NO ADVERSE EFFECTS TO THE PATIENT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437476 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE E3237727 00827002202320

    Patients

    Seq Age Sex Outcome Treatment
    1