BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUSPHERE 10 - CERECYTE MICROCOIL

    MDR report key: 5783543 · Received July 11, 2016

    Report

    Report Number
    2954740-2016-00147
    Event Type
    Injury
    Date Received
    July 11, 2016
    Date of Event
    June 23, 2016
    Report Date
    June 24, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K0022420
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: FUBUKI (ASAHI INTECC, 7FR), EXCELSIOR SL-10 (STRYKER, S-SHAPED), ENPOWER DCB (LOT UNKNOWN). (B)(4); EXPIRATION DATE AND LOT UNKNOWN. COMPLAINT CONCLUSION: THE MICRUSPHERE WAS NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. THE PRESCORE RUPTURE OF THE FIRST MICRUSPHERE COIL AND THE FAILURE TO DETACH AND PREMATURE DETACHMENT OF THE SECOND MICRUSPHERE COIL COULD NOT BE CONFIRMED WITHOUT PRODUCT RETURN FOR ANALYSIS. THE ROOT CAUSE OF THE EVENTS COULD NOT BE DETERMINED; HOWEVER, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENTS. SINCE THERE WAS NO EVIDENCE THE EVENTS WERE RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN UNRUPTURED LEFT INTERNAL CAROTID-POSTERIOR CEREBRAL ARTERY ANEURYSM, A MICRUSPHERE (CSP10030030/C11892) INTRODUCER SHEATH SPLIT OPEN EXPOSING THE DEVICE POSITIONING UNIT (DPU) AND A SECOND MICRUSPHERE (CSP10030030/LOT UNK) FAILED TO DETACH WITH ENPOWER CONTROL CABLE (ECB000182-00 / P11482) AND LATER DETACHED IN THE MICROCATHETER. THE FIRST MICRUSPHERE COIL WAS CHOSEN AS THE 1ST COIL TO BE INSERTED, AND ALTHOUGH THE PHYSICIAN IDENTIFIED THAT THE MIDDLE OF THE INTRODUCER SHEATH WAS SPLIT BEFORE INSERTING IT, NEVERTHELESS TRIED TO INSERT THE COIL INTO THE EXCELSIOR SL-10 MICROCATHETER; HOWEVER, WHILE TRYING TO DO SO, THE DPU PROTRUDED FROM THE SPLIT. IT WAS UNKNOWN WHEN THE SPLIT OCCURRED; HOWEVER, THE SPLIT WAS REALIZED WHEN THE PHYSICIAN STARTED THE INSERTION. THERE WAS NO REPORT OF DAMAGE TO THE MICROCOIL OR CLINICALLY SIGNIFICANT PROCEDURE DELAY. THE USE OF THE MICRUSPHERE WAS ABORTED, AND REPLACED WITH ANOTHER MICRUSPHERE OF THE SAME CATALOG #, LOT UNKNOWN. THE PHYSICIAN CONNECTED THE COMPLAINT CABLE TO THE NEW MICRUSPHERE FOR THE ELECTRICAL CHECK, WHICH WAS SUCCESSFUL, AND THE MICRUSPHERE WAS DELIVERED TO THE TARGET ANEURYSM. HOWEVER, WHEN THE PHYSICIAN PRESSED THE DETACHED BUTTON, THE MICROCOIL COULD NOT BE DETACHED DESPITE THE SIGNAL BEEPING. THE PHYSICIAN RE-PRESSED THE DETACH BUTTON 10 MORE TIMES, BUT TO NO AVAIL. THE CABLE (CATALOG/LOT UNKNOWN) AND THE DCB WERE REPLACED WITH NEW DEVICES, BUT THE MICROCOIL STILL COULD NOT BE DETACHED. THE PHYSICIAN EVENTUALLY GAVE UP DETACHING THE COIL, AND STARTED TO RECOVER THE COIL. HOWEVER, THE MICROCOIL GOT DETACHED WHEN ABOUT 1CM OF IT WAS WITHDRAWN BACK INTO THE MICROCATHETER. THE DETACHED MICROCOIL WAS SUCCESSFULLY PUSHED INTO THE ANEURYSM BY USING THE DPU. THE COIL DID NOT STRETCH PRIOR TO DETACHMENT, AND THE EVENT DID NOT RESULT IN DISRUPTION/REDUCTION IN ARTERIAL BLOOD FLOW. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES, AND THERE WERE NO PATIENT INJURIES OR COMPLICATIONS. THE SAME DCB WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. DUE TO THE EVENTS, THE PROCEDURE WAS DELAYED FOR 15 MINUTES, HOWEVER, THE DELAY WAS NOT CLINICALLY SIGNIFICANT. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. THE COMPLAINT PRODUCTS WERE DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437304 MICRUSPHERE 10 - CERECYTE MICROCOIL CNV DCS COILS HCG MEDOS INTERNATIONAL SARL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention