BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 18 - CERECYTE MICROCOIL

    MDR report key: 4060170 · Received September 4, 2014

    Report

    Report Number
    1226348-2014-00338
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    December 24, 2010
    Report Date
    December 24, 2010
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). COMPLAINT CONCLUSION: THERE WAS NO PROBLEM DURING THE ELECTRICAL CHECK: HOWEVER, AFTER THE PRESIDIO 18 CERECYTE MICROCOIL WAS DEPLOYED INTO THE ANEURYSM, THE SYSTEM READY LAMP DID NOT ILLUMINATED WHEN CONNECTED TO THE CABLE. THE DCB AND THE CABLE WERE REPLACED, BUT THE SAME PROBLEM OCCURRED. THE COIL WAS TO BE REMOVED; HOWEVER, THE COIL DETACHED INSIDE THE SL-10 MICROCATHETER WITHOUT ANY INTENT. THERE WAS NO SERIOUS INJURY OR REQUIRED INTERVENTION AS A RESULT OF THE EVENT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE; THE EXACT ROOT CAUSE OF THE PROBLEM REPORTED COULD NOT BE DETERMINED. THE COIL MAY HAVE ANCHORED ON THE ANEURYSM OR THE MICROCATHETER DURING WITHDRAWAL, WHICH MAY HAVE CONTRIBUTED TO THE DETACHMENT WITHIN THE MICROCATHETER. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY RELEVANT DISCREPANCIES; DESIGN OR QUALITY CONCERNS. SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE COMPLAINT, NO CORRECTIVE ACTIONS WERE TAKEN. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS THE RESULT OF A RECENT FDA AUDIT AND WITH ACCORDANCE TO THE REQUIREMENTS OF CODE OF FEDERAL REGULATIONS - 21 CFR PART 803, MEDICAL DEVICE REPORTING.

    Description of Event or Problem · 1

    THERE WAS NO PROBLEM DURING THE ELECTRICAL CHECK; HOWEVER, AFTER THE PRESIDIO 18 CERECYTE MICROCOIL WAS DEPLOYED INTO THE ANEURYSM, THE SYSTEM READY LAMP DID NOT ILLUMINATED WHEN CONNECTED TO THE CABLE AND THE COIL COULD NOT DETACH. THE DCB AND THE CABLE WERE REPLACED, BUT THE SAME PROBLEM OCCURRED. THE COIL WAS TO BE REMOVED; HOWEVER, THE COIL DETACHED INSIDE THE SL-10 MICROCATHETER WITHOUT ANY INTENT. THERE WAS NO SERIOUS INJURY OR REQUIRED INTERVENTION AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540576 PRESIDIO 18 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA F58915

    Patients

    Seq Age Sex Outcome Treatment
    1