BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCANLAN VASCULAR TUNNELER SHEATH

    MDR report key: 2848642 · Received October 23, 2012

    Report

    Report Number
    2126670-2012-00005
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 23, 2012
    Manufacturer
    SCANLAN INTERNATIONAL, INC.
    Product Code
    DWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SCANLAN INTERNATIONAL INC. HAS CONTACTED THE REPORTER AND THE REPORTER HAS INDICATED THAT NO FURTHER INFORMATION IS AVAILABLE. DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 1

    PT TO SURGERY FOR FEMORAL-POPLITEAL TIBIAL BYPASS-RIGHT. DURING THE SURGICAL PROCEDURE, THE SURGEON INSERTED THE PLASTIC TIP FROM THE SCANLAN TUNNELER, WHICH BECAME DISCONNECTED FROM THE TUNNELER ITSELF DURING THE CREATION OF THE ANATOMICAL TUNNEL. AFTER EXTENSIVE EFFORTS, IT COULD NOT BE PALPATED IN THE TRACK. IT WAS LEFT IN THE MUSCLE OF THE THIGH. AS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCANLAN VASCULAR TUNNELER SHEATH VASCULAR TUNNELER SHEATH DWS SCANLAN INTERNATIONAL, INC. 9009-18 5124501

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other