BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMASH BALLOON DILATATION CATHETER

    MDR report key: 1241057 · Received November 20, 2008

    Report

    Report Number
    2134265-2008-04405
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: 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 HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMASH BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R