BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 6725605 · Received July 19, 2017

    Report

    Report Number
    2954740-2017-00213
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    June 22, 2017
    Report Date
    June 27, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    UDI-DI
    00878528008187
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS FOLLOW-UP MDR REPORT BEING SUBMITTED WITH ASSOCIATED MFR# 2954740-2017-00213. PRODUCT RETURNED FOR INVESTIGATION. THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING, HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. NO CONCLUSIONS ARE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED WITH ITS INNER POUCH. LOT NUMBER AND PRODUCT ON INNER POUCH MATCH THE COMPLAINT ITEM. THE DPU IS COMPLETELY UNSHEATHED; THE RESHEATHING TOOL IS ADVANCED ALL THE WAY TO THE GREEN INTRODUCER. THERE IS NO EMBOLIC COIL ATTACHED TO THE DPU. THE RH COIL APPEARS TO HAVE RECEIVED HEAT AND MELTED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL REJECTED PRODUCT WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE COMPLAINT THAT THE EMBOLIC COIL FAILED TO DETACH IS NOT CONFIRMED. THE EVIDENCE OF THE DARKENING OF THE RH COIL INDICATES THAT THE DETACHMENT CYCLE WORKED AS EXPECTED, AND THE COIL DETACHED PROPERLY IN THE TARGET SITE. ADDITIONALLY, SINCE THE HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS NO COIL ATTACHED TO THE DPU WHEN IT WAS WITHDRAWN, AND ALSO THAT THE EMBOLIC COIL COULD NOT BE LOCATED IN THE MICROCATHETER, IT IS LIKELY THAT THE EMBOLIC COIL WAS PROPERLY DETACHED, BUT THAT ANOTHER PART OF THE DEVICE WAS MISTAKEN FOR THE EMBOLIC COIL UNDER FLUOROSCOPY.

    Additional Manufacturer Narrative · 1

    THIS IS INITIAL MDR REPORT BEING SUBMITTED WITH ASSOCIATED MFR# 2954740-2017-00213. (B)(4). CONCOMITANT DEVICES: LEO BABY STENT, 1. ENPOWER CONTROL BOX & CONNECTING CABLE CCB E1: REPORTER PHONE# +49 (9131) 85 39388. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. NO CONCLUSIONS ARE MADE AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE A DELTAPLUSH COIL (CPL10020130/C27713) FAILED TO DETACH. PRIOR TO ATTEMPT TO DETACH, IT WAS VERIFIED UNDER FLURO THAT THERE WAS NO STRESS AGAINST THE MICROCATHETER OR DELIVERY TUBE. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL TEN TIMES BUT REPORTED THAT IT DID NOT WORK. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED, THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. UNDER FLUORO THE ENTIRE COIL WAS REMOVED, HOWEVER ONLY THE PUSHER WIRE CAME OUT WITHOUT THE COIL. IT WAS THEN TRIED TO PUSH THE COIL WITH A MICROWIRE BUT THERE SEEMED TO BE NO COIL IN THE MICROCATHETER AS IT COULD NOT BE SEEN UNDER FLUORO. THE MICROCATHETER WAS IN THE ANEURYSM WHEN THIS EVENT OCCURRED. THE LOCATION OF THE COIL IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH A SAME LIKE PRODUCT WITH A DELAY OF 15 MINUTES. THE SAME CONNECTING CABLE AND DCB WERE USED SUCCESSFULLY WITH SUBSEQUENT COIL. THE PROCEDURE WAS FOR RE-TREATMENT OF MIDDLE CEREBRAL ARTERY ANEURYSM WHICH WAS INITIALLY TREATED WITH A WEB DEVICE WITH INSUFFICIENT RESULTS. THE RE-TREATMENT AS PERFORMED USING BABY-LEO STENT AND COILS. THERE WERE NO INJURIES TO THE PATIENT. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS RELATED TO THE DEVICE OR REPORTED EVENT. THERE WERE NO DAMAGES NOTED ON THE COIL SYSTEM PRIOR TO USE. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506520 DELTAPLUSH - CERECYTE MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA C27713 00878528008187

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR