BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIO ASPIRATION CATHETER

    MDR report key: 1203367 · Received October 15, 2008

    Report

    Report Number
    2134265-2008-03041
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Report Date
    March 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DXE
    PMA / PMN Number
    K051880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE RIO ASPIRATION CATHETER WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE RIO ASPIRATION CATHETER 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 AN UNSPECIFIED PROCEDURE, THE SHAFT OF A RIO ASPIRATION CATHETER BROKE OUTSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIO ASPIRATION CATHETER DXE CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC 39052-001

    Patients

    Seq Age Sex Outcome Treatment
    1