BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX 2 360

    MDR report key: 1211663 · Received October 16, 2008

    Report

    Report Number
    1211663
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    October 11, 2008
    Report Date
    October 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THERE WERE TWO ISSUES THAT OCCURRED. THE FIRST WAS THAT THE FLUOROSCOPY UNIT GOT STUCK ON THE CONE FUNCTION DURING CEREBRAL COILING. THE MACHINE HAD TO BE REBOOTED, AND IT TOOK 7 MIN TO GET IT TO RESET. THE FLUORO MACHINE REP. WAS ALSO CALLED AND THE SYSTEM WAS REBOOTED WITH NO FURTHER PROBLEMS. THE SECOND ISSUE INVOLVED RETAINED COIL FRAGMENTS. THE COIL WAS DETERMINED TO BE TOO LARGE FOR THE AREA IT WAS BEING PLACED, AND WHEN THE PHYSICIAN TRIED TO PULL IT BACK, IT GOT STUCK. THE PT ALSO HAD A VERY TORTUOUS ANATOMY. A SNARE WAS USED TO REMOVE THE PIECES THAT BROKE. SOME PIECES WERE UNABLE TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX 2 360 COIL, EMBOLIZATION, NEUROVASCULAR HCG BOSTON SCIENTIFIC CORP. STANDARD SR 9MMX30CM 11204034

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR OTHER| OTHER