BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1694066 · Received May 19, 2010

    Report

    Report Number
    2939204-2010-00427
    Event Type
    Injury
    Date Received
    May 19, 2010
    Report Date
    February 7, 2006
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K050700 AND K031168. ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE LABELING FOUND THAT THE DIRECTIONS FOR USE NOTES THAT MULTIPLE PROCEDURES MAY BE REQUIRED TO OCCLUDE AN ANEURYSM. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    APPROXIMATELY SIX MONTHS AFTER THE COIL EMBOLIZATION OF A LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE PATIENT UNDERWENT A SECOND PROCEDURE TO TREAT THE REOCCURRENCE OF THE ANEURYSM. THE EXACT DATE OF THE SECOND PROCEDURE WAS NOT PROVIDED. THERE WERE NO REPORTED CLINICAL CONSEQUENCES. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX DETACHABLE COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK UNK536

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention (B) (4) - MATRIX2 ULTRASOFT 360 SR| (B) (4) - MATRIX ULTRASOFT| (B) (4) - MATRIX2 SOFT 360 SR| (B) (4) - MATRIX ULTRASOFT