BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX2 ULTRASOFT 360 SR COIL

    MDR report key: 1201790 · Received October 15, 2008

    Report

    Report Number
    2939204-2008-00474
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ANEURYSM EMBOLIZATION AT THE LEFT VERTEBRAL ARTERY (VA), THE PHYSICIAN SUCCESSFULLY DELIVERED TEN COILS WITHOUT ANY ISSUES. HOWEVER, THE ELEVENTH COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE PUSHER WIRE AND VISUALLY CONFIRMED THAT THE COIL HAD NOT DETACHED. THE PHYSICIAN WAS UNABLE TO DEPLOY THE COIL INTO THE ANEURYSM AGAIN. AS THE COIL WAS BEING WITHDRAWN, IT PREMATURELY DETACHED. THE PHYSICIAN SUCCESSFULLY REMOVED THE COIL USING A GOOSE NECK SNARE AND THE MICROCATHETER. THERE WAS NOT REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX2 ULTRASOFT 360 SR COIL (HCG) DETACHABLE COIL HCG BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION 498510-SR 11719465

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention POWER SUPPLY| BOSTON SCIENTIFIC EXCELSIOR SL-10 PRE-SHAPED 45| 7FR BRITE TIP GUIDE CATHETER| SILVERSPEED 10 GUIDEWIRE| 10 COILS| GOOSE NECK SNARE