BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 - CERECYTE MICROCOIL

    MDR report key: 2904586 · Received January 9, 2013

    Report

    Report Number
    2954740-2013-00009
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K062036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW OF THE FILE, THE REPORTED EVENT DOES NOT MEET THE CRITERIA FOR REPORTING. NO FURTHER REPORTS WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ENPOWER CONTROL CABLE (ECB000182-00/12389). UNKNOWN DETACHMENT CONTROL BOX. COMPETITOR'S COIL (AXIUM/COVIDIEN (B)(4), DETAILS UNKNOWN). ENPOWER CONTROL CABLE (ECB000182-00, LOT UNKNOWN).

    Description of Event or Problem · 1

    THE PROCEDURE WAS COIL EMBOLIZATION OF INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE EVENT HAPPENED DURING THE PROCEDURE. IT WAS NOTED THAT THE PHYSICIAN COULD NOT DETACH A PRESIDIO (DETAILS UNKNOWN) USING AN ENPOWER CONTROL CABLE (ECB000182-00/12389). THE DETACHMENT BUTTON WAS PRESSED SEVERAL TIMES AND AN INTERMITTENT TONE SOUND WAS NOTED WHEN DETACHMENTS WERE ATTEMPTED. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT ILLUMINATED AND THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE TYPE OF DETACHMENT CONTROL BOX USED WITH THE PRODUCT WAS NOT PROVIDED. IT IS ALSO UNKNOWN IF THE DETACHMENT CONTROL BOX WAS REPLACED OR NOT. PRIOR TO THE COMPLAINT PRODUCT, ONE COMPETITOR'S COIL (AXIUM/COVIDIEN (B)(4), DETAIL UNKNOWN) WAS SUCCESSFULLY PLACED IN THE ANEURYSM. WHEN HE REPLACED THE CABLE FOR A NEW ONE (ECB000182-00, LOT UNKNOWN), HE WAS ABLE TO DETACH THE SAME PRESIDIO WITHOUT ANY PROBLEM. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. IT IS UNKNOWN HOW MANY COILS WERE SUCCESSFULLY PLACED DURING THE PROCEDURE. THE PRODUCT WAS 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. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE DEVICE BY VISUAL INSPECTION. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND NO ISSUES WERE NOTED. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE ANEURYSM OR IN THE MICROCATHETER. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12069 PRESIDIO 10 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1