BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 1132772 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03589
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSPECTION OF THE FACILITY'S STOCK OF JAG PRECURSOR 035/450 ST AND JAG PRECURSOR 025/450 ST GUIDEWIRES THE TIP ABNORMALITIES WERE DISCOVERED. DURING INSPECTION, IT WAS DISCOVERED THAT THE TIPS OF THE GUIDEWIRES APPEARED 'SHARPENED" AS IF THEY HAD BEEN "CUT OBLIQUELY". THE TIP OF THE GUIDE WIRES ALSO APPEARED "MORE ANGULATED THAN NORMAL" DURING EXPERIMENTALA CANNULATION OF THE DEVICE. THE HYDROPHILIC TIP WAS MEASURED TO BE LONGER THAN 5CM, ALMOST 5.5CM; LONGER THAN THE OTHER "NORMAL" JAGWIRE. THE DEVICES WERE NOT USED IN A PATIENT PROCEDURE AND DID NOT CONTACT A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE EZB BOSTON SCIENTIFIC M0055658011 9790513

    Patients

    Seq Age Sex Outcome Treatment
    1