BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 2921139 · Received January 17, 2013

    Report

    Report Number
    2954740-2013-00015
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 31, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080437
    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 (M10541) 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: EV3 10 MICRO-CATHETER, UNKNOWN COMPETITOR COIL.

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER INFORMATION WILL BE SUBMITTED FOR THIS FILE.

    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.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE COIL COULD NOT BE PUSHED OUT FROM THE EV3 10 MICRO-CATHETER. THE COIL MADE IT ALL THE WAY THROUGH THE MICROCATHETER BUT WHEN THE PHYSICIAN TRIED TO DEPLOY THE COIL, IT COULD NOT BE PUSHED OUT TO TREAT THE ANEURYSM. THE COIL WAS NOT IN THE ANEURYSM WHEN THE EVENT OCCURRED. THE COIL WAS REMOVED AND ANOTHER COMPANY'S COIL WAS USED TO COMPLETE THE PROCEDURE. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WERE NO DAMAGES NOTED ON THE COIL AND MICROCATHETER PRIOR TO AND AFTER USE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26093 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA M10541

    Patients

    Seq Age Sex Outcome Treatment
    1