BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX .014"

    MDR report key: 481390 · Received August 27, 2003

    Report

    Report Number
    6000078-2003-00133
    Event Type
    Malfunction
    Date Received
    August 27, 2003
    Date of Event
    July 25, 2003
    Report Date
    August 26, 2003
    Manufacturer
    BOSTON SCIENTIFIC CORP. NEUROVASCULAR DIV.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS NOTIFIED OF THE FOLLOWING EVENT WHICH OCCURRED DURING A PTA OF A RIGHT SUBCLAVIAN ARTERY: THE WIRE WAS INSERTED INTO AN INTEPASS 3 CATHETER (IP CH-24294, LOT 030617/TERUMO), AND WAS SUBSEQUENTLY TORQUED. THE WIRE WAS THEN BROKEN 1.5CM PROXIMAL TO THE CATHETER HUB. THE WIRE WAS SUCCESSFULLY REMOVED. ACCORDING TO PHYSICIAN, NO RESISITANCE WAS FELT DURING USE. THE WIRE WAS SLIGHTLY TORQUED INITIALLY AND THEN BROKEN WHEN IT WAS FURTHER TORQUED. ANOTHER TRANSEND EX WAS TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX .014" GUIDEWIRE DQX BOSTON SCIENTIFIC CORP. NEUROVASCULAR DIV. * 5589501

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO BRAND NAME: TERUMO, TYPE OF DEVICE: GUIDEWIRE.| LOT #030617.| BRAND NAME: INTERPASS CATHETER, CATALOG #CH-24294,