BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRO 14 GUIDEWIRE

    MDR report key: 917073 · Received September 20, 2007

    Report

    Report Number
    6000078-2007-00240
    Event Type
    Injury
    Date Received
    September 20, 2007
    Report Date
    August 24, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL DIFFERENT GUIDEWIRES WERE USED DURING THIS EVENT, BUT IT WAS NOT SPECIFIED AS IN WHICH GUIDEWIRE WAS SUGGESTED TO HAVE RUPTURED THE ARTERY. HOWEVER, IT WAS REPORTED THAT NO PRODUCT FAILURE OR DESIGN ISSUE WAS ALLEGED ON THE DEVICE IN QUESTION). ADD'L 510(K) #: K023700, K002907.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO THE MANUFACTURER: "PATIENT PRESENTING WITH SUBARACHNOID HEMORRHAGE (SAH AND SEIZURES. DIAGNOSTIC PROCEDURES YIELDED A BASILAR ANEURYSM PLUS 6 MORE ANEURYSMS. COILNG WAS PERFORMED ON BASILAR ANEURYSM. NORMAL RECOVERY FOR PATIENT ENSUED UNTIL DAY 13 POST-OP. HEMORRHAGE AND VASOSPASM EVIDENT ON ANGIOGRAM. PATIENT WAS STABLE DURING PROCEDURE, BUT SLOW TO AWAKEN. A CT (COMPUTER TOMOGRAPHY) SCAN SHOWED EVIDENCE OF AN MCA (MIDDLE CEREBRAL ARTERY) RUPTURE. IT WAS SUGGESTED THAT A GUIDEWIRE RUPTURED THE ARTERY. NO PRODUCT FAILURE OR DESIGN ISSUE WAS ALLEGED ON THE DEVICE IN QUESTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 14 GUIDEWIRE DQX: GUIDEWIRE DQX BOSTON SCIENTIFIC CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention MIRAGE GUIDEWIRE| PROWLER 14 MICROCATHETER| HYPERGLIDE 4X15 BALLOON