BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6000130-2006-00045

    MDR report key: 691467 · Received March 10, 2006

    Report

    Report Number
    6000130-2006-00045
    Event Type
    Injury
    Date Received
    March 10, 2006
    Date of Event
    February 8, 2006
    Report Date
    February 8, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE PT2 MODERATE SUPPORT GUIDE WIRE FRACTURED. THE PATIENT WAS UNDERGOING HEART CATHETERIZATION FOR ANGINA. AN ATW GUIDE WIRE WAS USED TO CROSS THE LEFT CIRCUMFLEX STENOSIS. WIRE POSITION WAS LOST, AND DURING REWRITING OF THE ARTERY, AN EPISODE OF TYPE C DISSECTION TO THE MID-LEFT CIRCUMFLEX ARTERY WAS NOTED PROXIMAL TO THE LESION. FOLLOWING TWO UNSUCCESSFUL ATTEMPTS TO CROSS THE LESION WITH DIFFERENT GUIDE WIRES, THE PT2 MODERATE SUPPORT GUIDE WIRE FRACTURED IN THE BALLOON. THE PHYSICIAN WAS ABLE TO SNARE THE FRACTURED WIRE. BALLOON INTERVENTION WAS USED AND THE LESION WAS SUCCESSFULLY STENTED WITH A DRUG ELUTING STENT. PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DQX BOSTON SCIENTIFIC PT2 MODERATE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention