BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE WIRES

    MDR report key: 550106 · Received October 20, 2004

    Report

    Report Number
    6000130-2004-00173
    Event Type
    Injury
    Date Received
    October 20, 2004
    Date of Event
    September 17, 2004
    Report Date
    September 20, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR'S REPORT# 6000130-2004-0174. DURING A PTCA/STENTING TREATMENT PROCEDUE, THE GUIDEWIRE TIP FRACTURED. THE PHYSICIAN WAS ATTEMPTING TO TREAT A BIFURCATED ANTERIOR LATERAL/1ST OBTUSE MARGINAL LESION VIA A 'T-STENT' PROCEDURE. TWO WIRES WERE USED IN THIS PROCEDURE: A PT2 MODERATE SUPPORT 300 CM STR AND A CHOICE 300 PT J. THE PHYSICIAN PREDILATED THE LESION WITH 2.0 MM AND 3.0 MM PTCA BALLOONS, THEN DEPLOYED TWO TAXUS STENTS (2.50/12 MM ADN 2.75/28 MM). POST DEPLOYMENT OF THE STENTS, THE GUIDEWIRES WERE REMOVED AND ONE OF THE WIRES HAD A FRACTURED TIP, BUT THE PHYSICIAN WAS UNABLE TO IDENTIFY THE WIRE THAT FRACTURED. HE WAS, HOWEVER, ABLE TO RETRIEVE THE SEPARATED TIP BY USING A 2 MM MICRO SNARE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRES PT2 PTCA GUIDEWIRE DQX BOSTON SCIENTIFIC PT2 MODERATE SUPPORT 300CM STR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention