BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 2560683 · Received April 30, 2012

    Report

    Report Number
    MW5025259
    Event Type
    Malfunction
    Date Received
    April 30, 2012
    Date of Event
    April 13, 2012
    Report Date
    April 30, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    ODG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ENDOSCOPIC ULTRASOUND WITH FINE-NEEDLE ASPIRATION. ACCORDING TO THE REPORT "UPON REMOVING THE STYLET FROM THE CATH IT WAS NOTED TO BE IN SPIRAL TWISTS THROUGH THE ENTIRE LENGTH OF THE STYLET.. NORMALLY THE WIRE IS STRAIGHT." DR (B)(6), DR (B)(6). THE FIRST EXPECT ASPIRATION NEEDLE WAS OPEN AND COULD NOT BE USED. WHEN THE SURGEON TRIED TO USE THIS ONE, SHE NOTED THAT HE WAS "UNABLE TO NAVIGATE NEEDLE DUE TO LIMITED FLEXIBILITY." DR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC EXPECT ULTRASOUND ASPIRATION NEEDLE 25GA ODG BOSTON SCIENTIFIC UPN PRODUCT#M005500 13615943C1
    2 BOSTON SCIENTIFIC EXPECT ULTRASOUND ASPIRATION NEEDLE 25GA ODG BOSTON SCIENTIFIC UPN PRODUCT # M005500 14658194C1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR