BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCANLAN VASCULAR TUNNELER SHEATH

    MDR report key: 2669647 · Received June 28, 2012

    Report

    Report Number
    2126670-2012-00002
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    April 26, 2012
    Report Date
    June 28, 2012
    Manufacturer
    SCANLAN INTERNATIONAL, INC.
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SCANLAN INTERNATIONAL, INC HAS MADE NUMEROUS ATTEMPTS TO GAIN FURTHER INFO REGARDING THIS REPORTED EVENT. CONTACT POINT IS A RISK MANAGER WITH NO DIRECT KNOWLEDGE OF THE EVENT. UNABLE TO CONTACT PRACTITIONERS WHO REPORTED EVENT. DEVICE DISPOSITION UNK.

    Description of Event or Problem · 1

    MALE REQUIRING SCHEDULED VASCULAR PROCEDURE OF RIGHT LOWER EXTREMITY. A SCANLAN VASCULAR TUNNELING DEVICE WAS USED TO PREPARE THE LOWER EXTREMITY FOR REVASCULARIZATION. A GREEN CAP ON ONE END, USED AT THE DISTAL END, BECAUSE DISLODGED WHILE INSERTING THROUGH TISSUE AND IS HIGHLY SUSPECTED TO BE RETAINED WITHIN THE SUBCUTANEOUS TISSUE. THE RADIOPAQUE CAP WAS NOT LOCATED USING FLUOROSCOPY OR ULTRASONOGRAPHY. NO PREDICTED CHANGE IN THE LENGTH OF STAY OR CHANGE IN TREATMENT PLAN AT THIS TIME. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCANLAN VASCULAR TUNNELER SHEATH VASCULAR TUNNELER SHEATH DWS SCANLAN INTERNATIONAL, INC. NOT REPORTED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1