BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARI-LASE INTRODUCER SHEATH

    MDR report key: 2914254 · Received January 14, 2013

    Report

    Report Number
    2134812-2013-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 14, 2013
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    DYB
    PMA / PMN Number
    K043525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A VARI-LASE INTRODUCER SHEATH WAS BEING USED IN A CLINICAL PROCEDURE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DILATOR FROM THE SHEATH, THE CAP ON THE SHEATH DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20213 VARI-LASE INTRODUCER SHEATH PERCUTANEOUS SHEATH INTRODUCER DYB VASCULAR SOLUTIONS, INC. 7402 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1