BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 18 - CERECYTE MICROCOIL

    MDR report key: 3955296 · Received July 24, 2014

    Report

    Report Number
    1226348-2014-00162
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 3, 2014
    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: THE DEVICES WERE NOT AVAILABLE FOR ANALYSIS. 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 FAILURE OF COIL DETACHMENT COULD NOT BE CONFIRMED WITHOUT PRODUCT RETURN FOR ANALYSIS. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED, AND IT IS NOT POSSIBLE TO DETERMINE FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT BASED ON INFORMATION PROVIDED. THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE FAILURE TO DETACH, THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR. THIS IS 1 OF 2 MDRS THAT ARE BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MANUFACTURE REPORT NUMBERS OF 1226348-2014-00162 AND 1226348-2014-00161.

    Description of Event or Problem · 1

    DURING THE COIL EMBOLIZATION FOR TYPE 2 ENDOLEAK AT AN UNSPECIFIED TARGET LESION SITE, THE PHYSICIAN WAS SUCCESSFULLY ABLE TO ADVANCE AN UNSPECIFIED EXCELSIOR 1018 (TYPE UNKNOWN) TO THE TARGET LESION SITE, AND PLACE TWO PRESIDIO (PC4181950-30 / C23384 AND PC4181343-30/C25098) INSIDE THE ANEURYSM; HOWEVER, BOTH COILS FAILED TO DETACH. THEY WERE SAFELY REMOVED AND NEW COILS (LOT UNKNOWN) WERE USED WITH THE SAME CABLE AND BOX. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES, AND THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. WHETHER THE PROCEDURE WAS DELAYED DUE TO THE COMPLICATION IS UNKNOWN. FOR THE DETACHMENT DEVICE, AN UNSPECIFIED EMPOWER (TYPE UNKNOWN) AND UNKNOWN CABLE WERE USED. THE COMPLAINT PRODUCTS WERE NEW AND HAD BEEN STORED PER LABELING INSTRUCTIONS; HOWEVER, IT IS UNKNOWN IF THE PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED; HOWEVER, IT WAS REPORTED THAT THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. NO DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433539 PRESIDIO 18 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C25098

    Patients

    Seq Age Sex Outcome Treatment
    1