BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX2 STANDARD 3D COIL

    MDR report key: 1171576 · Received September 17, 2008

    Report

    Report Number
    2939204-2008-00376
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    March 19, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIV.
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL AND UPON WITHDRAWAL, THE COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER SIMILAR DEVICE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX2 STANDARD 3D COIL (HCG) NEUROVASCULAR EMBOLIZATION COIL HCG BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIV. 475510 11080810

    Patients

    Seq Age Sex Outcome Treatment
    1