BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCANLAN

    MDR report key: 581225 · Received February 17, 2005

    Report

    Report Number
    581225
    Event Type
    Injury
    Date Received
    February 17, 2005
    Date of Event
    January 13, 2005
    Report Date
    February 17, 2005
    Manufacturer
    SCANLAN INTL., INC.
    Product Code
    DWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE BULLDOG CLAMP END OF A VASCULAR TUNNELER BROKE OFF IN THE BULLET TIP OF THE TUNNELER SHEATH DURING A PROCEDURE. X-RAY WAS CALLED IN AND FLUROSCOPY PERFORMED TO LOCATE AND RETRIEVE THE BROKEN PIECE. ANESTHESIA WAS PROLONGED. RESULTS OF MANUFACTURER'S EVALUATION: THE DISTAL TIP OF THE TUNNELER AND HE BULLDOG CLIP WERE REVIEWED BOTH WITH THE UNAIDED EYE AND ALSO UNDER 10X MAGNIFICATION. VISUAL EVIDENCE IS PRESENT INDICATING THE TIP WAS BENT FROM SIDE TO SIDE (INDICATED BY THE STRETCHING AND ULTIMATELY) CAUSING THE SHAFT TO BECOME FRACTURED AND ULTIMATELY BREAKING OFF COMPLETELY. THE DARK COLOR SEEN IN THE FRACTURE AREA INDICATES THAT THE FRACTURE HAPPENED SOME TIME AGO. THE FRACTURE FACE (SHEAR) WAS EXPOSED TO THE ELEMENTS CAUSING A DARK COLOR CHANGE WHERE THE FRACTURE BEGAN. THE AREA THAT IS A LIGHTER COLOR IS THE PART OF THE SHAFT THAT BROKE LAST AS THIS AREA WAS NOT EXPOSED TO ENVIRONMENTAL ELEMENTS AS LONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCANLAN VASCULAR TUNNELER DWS SCANLAN INTL., INC. 9009-24 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention