BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRO 14 GUIDEWIRE

    MDR report key: 1241717 · Received November 20, 2008

    Report

    Report Number
    2939204-2008-00622
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    April 27, 2007
    Report Date
    November 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN AS THE UPN AND BATCH NUMBERS WERE NOT DISCLOSED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY. THERE WAS NO ALLEGED DEVICE MALFUNCTION OR NONCONFORMANCE. THE PHYSICIAN BELIEVED THE EVENT WAS RELATED TO THE PROCEDURE AND POSSIBLY TO THE OTHER DEVICES USED IN THE PROCEDURE.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A RUPTURED SACCULAR ANTERIOR COMMUNICATING ARTERY (ACA) ANEURYSM AND A GRADE 1 ACUTE SUBARACHNOID HEMORRHAGE. FOLLOWING THE SUCCESSFUL PLACEMENT OF TWO COILS, ANGIOGRAPHY REVEALED A FOCAL THROMBUS WITHIN THE ORIGIN OF THE RIGHT ACA, A2 SEGMENT. THIS WAS TREATED WITH TWO SEPARATE WEIGHT-BASED BOLUSES OF INTRAVENOUS EPTIFIBATIDE FOR A TOTAL DOSE OF 15.8CC. FINAL ANGIOGRAPHY REVEALED THE THROMBUS WAS RESOLVED AND THE ACA WAS PATENT. THE EVENT WAS REPORTED TO BE "RESOLVED WITH NO CLINICAL EFFECTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 14 GUIDEWIRE (DQX) GUIDEWIRE DQX BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention 15| TRANSEND GUIDEWIRE| EXCELSIOR SL10 PRESHAPED 45 MICROCATHETER| TWO MATRIX2 COILS (BOSTON SCIENTIFIC).