BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 - CERECYTE MICROCOIL

    MDR report key: 2925629 · Received January 22, 2013

    Report

    Report Number
    2954740-2013-00020
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: - ORBIT RDFL COMPLEX MINI COIL ((B)(4)); - UNKNOWN MICROCATHETER; - UNKNOWN BLACK DCB; - UNKNOWN CONNECTING CABLE; - 5 UNKNOWN COILS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2013-00028 AND 2954740-2013-00020.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PRESIDIO 10 CERECYTE MICROCOIL 8 MM X 29 CM ((B)(4)) COULD NOT BE DETACHED WHILE THE COIL WAS POSITIONED AT THE TARGET, AND WHILE PLANNING TO FILL THE ANEURYSM WITH THE FIFTH COIL ORBIT RDFL COMPLEX MINI COIL ((B)(4)) WAS FOUND STRETCHED. DURING THE CASE, PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED ON THE PRESIDIO. THE FAULT LIGHT AND LOW BATTERY LIGHT WAS NOT SEEN DURING THE CASE. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THERE WERE NO DAMAGES NOTED ON THE MICROCATHETER AND ON THE PRESIDIO 10 CERECYTE MICROCOIL 8 MM X 29 CM ((B)(4)) PRIOR TO AND AFTER USE. DURING USE OF THE ORBIT, THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. THERE WERE NO DAMAGES NOTED ON THE ORBIT RDFL COMPLEX MINI COIL ((B)(4)) PRIOR TO USE. THE ORBIT RDFL COMPLEX MINI COIL ((B)(4)) AND MICROCATHETER WERE NOT REMOVED AS A UNIT, ONLY THE COIL WAS REMOVED. THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED. THE PHYSICIAN CHANGED TO ANOTHER COIL TO COMPLETE THE PROCEDURE. THE SAME DETACHMENT CONTROL BOX (BLACK), CONNECTING CABLE, AND MICROCATHETER WERE USED TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE TARGET SITE IS PCOM WITH A SIZE OF 7.4*7.5. THE PATIENT IS FINE. THE COMPONENTS ARE GOING TO BE RETURNED FOR ANALYSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31052 PRESIDIO 10 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G15008

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR