BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESHEATH

    MDR report key: 2842810 · Received October 24, 2012

    Report

    Report Number
    2842810
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 24, 2012
    Manufacturer
    THOMAS MEDICAL PRODUCTS, INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S LEFT AXILLARY VEIN WAS ACCESSED, A WIRE WAS INSERTED AND THE 8F SAFESHEATH WAS INTRODUCED OVER THE WIRE. THE ST JUDE LEAD (UNCLEAR WHETHER PACING LEAD OR DEFIBRILLATOR LEAD) WAS INSERTED VIA THE SAFESHEATH AND THE PHYSICIAN ATTEMPTED TO "PEEL-AWAY" THE SHEATH LEAVING THE LEAD IN PLACE. THE SAFESHEATH DID NOT COMPLETELY PEEL, FROM THE PROXIMAL END TO THE DISTAL TIP, BUT INSTEAD SEPARATED APPROXIMATELY 5CM PROXIMAL OF THE DISTAL TIP. THE ELECTROPHYSIOLOGIST HAD TO CUT THE REMAINING SHEATH, WITH SURGICAL SCISSORS, IN ORDER TO "FREE" THE LEAD FROM THE SHEATH- - THE LEAD WAS NOT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESHEATH PERCUTANEOUS INTRODUCER DYB THOMAS MEDICAL PRODUCTS, INC * S38628

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR