BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATEWAY PLUS Y ADAPTER KIT

    MDR report key: 1231072 · Received October 30, 2008

    Report

    Report Number
    2134265-2008-04153
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 30, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTL
    PMA / PMN Number
    K951089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY TREATMENT PROCEDURE, THE BOTTOM OF THE POUCH FOR THE GATEWAY PLUS Y ADAPTER KIT WAS OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY PLUS Y ADAPTER KIT DTL ADAPTER, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS DTL BOSTON SCIENTIFIC CORPORATION NA 2034487

    Patients

    Seq Age Sex Outcome Treatment
    1