BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCANLAN VASCULAR TUNNELER SHEATH

    MDR report key: 3020587 · Received March 21, 2013

    Report

    Report Number
    2126670-2013-00001
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 24, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SCANLAN INTERNATIONAL, INC.
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EXAMINED. NO EVIDENCE OF PRODUCT PROBLEM WAS DETECTED IN EVALUATED PRODUCT.

    Description of Event or Problem · 1

    PROCEDURE WAS A POPLITEAL TO FEMORAL, THE SURGEON HIT RESISTANCE, WENT TO BACK IT OUT, DURING BACKING IT OUT, THE TIP CAME OFF. THE C-ARM CAME IN TO LOCATE THE TIP, SO IT COULD BE REMOVED. THIS ADDED A 30 MINUTE DELAY TO THE PROCEDURE. NO PERMANENT INJURY TO PT. AS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118838 SCANLAN VASCULAR TUNNELER SHEATH VASCULAR TUNNELER SHEATH DWS SCANLAN INTERNATIONAL, INC. 9009-18 5155001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention