BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX2 360 DEGREES SOFT SR COIL

    MDR report key: 1060243 · Received June 11, 2008

    Report

    Report Number
    2939204-2008-00233
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    March 10, 2008
    Report Date
    May 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL MFR REPORT # 2939204-2008-00233 IS RELATED TO INITIAL MFR. REPORT # 2939204-2008-00232.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR THAT A CUSTOMER ENCOUNTERED DIFFICULTIES DURING USE OF A DETACHABLE COIL. THE PT WAS ADMITTED FOR TREATMENT OF A RUPTURED ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN ATTEMPTED TO PACK THE RUPTURED ANEURYSM WITH THE COILS. THE SIZE OF THE ANEURYSM BEING TREATED WAS 11.7 X 9.3MM. THE PT'S ANATOMY WAS REPORTED TO BE TORTUOUS. THIS COIL WAS "PLACE IN ANEURYSM AND CONFORM NICELY" HOWEVER UPON THE PHYSICIAN'S ATTEMPT TO DETACH THE COIL, IT WAS NOTICED THAT THE COIL HAD UNEXPECTEDLY DETACHED WITHIN THE ANEURYSM. AN ANGIOGRAM WAS PERFORMED POST PROCEDURE AND IT WAS FOUND THERE A "SMALL FILLING DEFECT IN THE MCA BRANCH". THE PT WAS DISCHARGED FROM THE HOSPITAL EXPERIENCING LEFT SIDED PARALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX2 360 DEGREES SOFT SR COIL HCG: NEUROVASCULAR EMBOLIZATION COIL HCG BOSTON SCIENTIFIC CORP. 490820-SR 11521506

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR HEPARIN| MATRIX2 360 DETACHABLE COIL| (MFR. REPORT #2939204-2008-00232)