BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHRO 2 GUIDEWIRE

    MDR report key: 1231569 · Received November 14, 2008

    Report

    Report Number
    2939204-2008-00582
    Event Type
    Death
    Date Received
    November 14, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION
    Product Code
    DQX
    PMA / PMN Number
    K042568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT. ADDITIONAL INFO WAS REC'D FROM THE USER FACILITY. THE PT DID NOT PRESENT WITH A RUPTURED ANEURYSM OR OTHER SIGNIFICANT CONDITION. THE PHYSICIAN DOES NOT ALLEGE ANY MALFUNCTION OR NON CONFORMANCE AGAINST THE DEVICE. CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE.

    Description of Event or Problem · 1

    TWO COILS WERE SUCCESSFULLY DETACHED IN THE BASILAR ARTERY ANEURYSM. THE FINAL ANGIOGRAM REVEALED THAT THE ANEURYSM WAS RUPTURED; WHEN THE RUPTURE OCCURRED WAS UNKNOWN. THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND DIED AN HOUR LATER. NO INFO WAS PROVIDED AS TO WHETHER ANY ACTION WAS TAKEN TO TREAT THE RUPTURED ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 2 GUIDEWIRE (DQX) GUIDEWIRE DQX BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION 2601 B14407

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death SL10 PRESHAPED 45 MICROCATHETERS| EXCELSIOR SL10| TWO GDC COILS (BOSTON SCIENTIFIC)