BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKATER INTRODUCER SYSTEM

    MDR report key: 1621246 · Received February 4, 2010

    Report

    Report Number
    1036710-2010-00003
    Event Type
    Malfunction
    Date Received
    February 4, 2010
    Date of Event
    January 14, 2010
    Report Date
    January 14, 2010
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SKATER INTRODUCER SYSTEM USED IN THE PROCEDURE IS NOT AVAILABLE FOR RETURN BY THE CUSTOMER. A REVIEW OF THE DHR FOUND NO DEFECTS OR DEVIATIONS DURING THE MANUFACTURE OF THE REPORTED WIRE. A PULL TEST FOR A WELD BREAK IS REQUIRED DURING THE PRODUCTION OF THE WIRE. THE REPORTED LOT PULLED ABOVE THE MINIMUM SPECIFICATION. INVENTORY OF THE REPORTED LOT NUMBER WAS STILL ON HAND. AN ADDITIONAL PULL TEST WAS COMPLETED ON ADDITIONAL SAMPLES, WHICH PULLED ABOVE THE MINIMUM SPECIFICATION. IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE DEFECT REPORTED WITHOUT REVIEWING THE CONDITION OF THE WIRE USED IN THE PROCEDURE. IF THE WIRE IS BENT DURING THE PROCEDURE, THE BENDING OR FLEXING OF STAINLESS STEEL CORE CAN REDUCE THE TENSILE STRENGTH. THE SAMPLE WIRE FROM THE REPORTED LOT PULLED ABOVE THE MINIMUM REQUIREMENT, AND NO DEFECT OR DEVIATIONS WERE NOTED; THEREFORE, THIS REPORT IS NOT CONSIDERED A SYSTEMATIC MANUFACTURING DEFECT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TIP OF THE GUIDEWIRE BROKE OFF IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKATER INTRODUCER SYSTEM INTRODUCER SYSTEM GCB ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 651506000 92161W2Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Other