BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCELSIOR SL-10 PRE-SHAPED 45 MICROCATHETER

    MDR report key: 1231568 · Received November 14, 2008

    Report

    Report Number
    2939204-2008-00581
    Event Type
    Death
    Date Received
    November 14, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    DQY
    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 EXCELSIOR SL-10 PRE-SHAPED 45 MICROCATHETER (DQY) CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION 168190 11846301

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death EXCELSIOR SL-10 MICROCATHETER| SYNCHRO2 GUIDEWIRE| TWO GDC COILS (BOSTON SCIENTIFIC)