BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUSPHERE 10 - CERECYTE MICROCOIL

    MDR report key: 2925066 · Received January 22, 2013

    Report

    Report Number
    2954740-2013-00017
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 23, 2012
    Report Date
    December 26, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K0022420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER, AND MICROCOILS WERE NOT RETURNED FOR ANALYSIS, AND THE LOT NUMBERS WERE NOT PROVIDED. THEREFORE, DHR COULD NOT BE CONDUCTED ON ANY OF THE DEVICES. SPASM AND CNS NERVE SYMPTOMS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH NEUROVASCULAR PROCEDURES. IMPLANTATION OR MANEUVERING OF MEDICAL DEVICES IS KNOWN TO CREATE IRRITABILITY WITHIN THE TARGET VASCULATURE LEADING TO ARTERIAL SPASM. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. THIS IS ONE OF MULTIPLE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 9616099-2013-00028, 2954740-2013-00017, AND 2954740-2013-00018.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, UNDER CONSTANT SALINE FLUSHING, THE PATIENT'S RIGHT (ICA) INTERNAL CAROTID ARTERY-SIPHON SUFFERED LITTLE SPASM THAT WAS TREATED WITH PAPAVERINE. DURING THE SPASM, THE DEVICES THAT WERE IN THE PATIENT, CONSISTED OF A CODMAN ENVOY GUIDING CATHETER, EV3 GUIDEWIRE, MICROSPHERE 3-5.4 COIL (CSP10030030/LOT UNK), DELTAPAQ 2-4 COIL AND MICRO-CATHETER. THE MICROSPHERE 3-5.4 AND DELTAPAQ 2-4 WERE IMPLANTED AS THE FIRST AND SECOND COIL. AFTER THAT, THE ANEURYSM CAVITY WAS ALMOST INVISIBLE UNDER FLUOROSCOPY, AND A DELTAPAQ MICROCOIL 1.5-2 WAS SELECTED AS THE THIRD COIL, ABUT DURING THE ADVANCEMENT PROCESS, THE COIL AND DELIVERY GUIDEWIRE COULD NOT BE PUSHED INTO THE MICROCATHETER PROXIMAL SECTION, ALTHOUGH SEVERAL ATTEMPTS WERE MADE, THE ATTEMPT WAS USELESS. AT LAST, THE DEVICE WAS CHANGED TO USE ANOTHER DELTAPAQ 1.5-2 TO COMPLETE THE PROCEDURE. AFTER THE EVENT, THE COIL WAS REMOVED WITHOUT LOSING TARGET SITE, AND THE SAME MICROCATHETER WAS USED WITH THE NEXT DEVICE. A DEDICATED AND CONSTANT SALINE SOURCE WAS UTILIZED AT ALL TIMES WITH THE MICROCATHETER. THE MICROCATHETER WAS NOT RE-SHAPED. AFTER THE MICROCOIL WOULD NOT ADVANCE, NO ADDITIONAL FORCE, TORQUE OR MANIPULATION WAS USED TO FURTHER ADVANCE THE DEVICES. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE DEVICES (KINK, BEND, STRETCHED, FRACTURE, SEPARATE, STENT, COIL RING FRACTURE, ETC), AND THE COIL REMAIN ATTACHED TO THE DELIVERY SYSTEM. THE TARGET SITE WAS A PCOM NOT RUPTURED ANEURYSM MEASURING 2-3MM. THERE WAS NO ADVERSE EVENT REPORTED AND THE COMPONENT WILL BE RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28890 MICRUSPHERE 10 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention UNKNOWN MICROCATHETER