BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRES

    MDR report key: 541956 · Received September 1, 2004

    Report

    Report Number
    6000130-2004-00133
    Event Type
    Malfunction
    Date Received
    September 1, 2004
    Date of Event
    February 7, 2004
    Report Date
    April 28, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PTCA TREATMENT PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE BALLOON OVER THE GUIDEWIRE AS THE GUIDEWIRE BECAME TRAPPED IN THE GUIDEWIRE LUMEN OF THE BALLOON. THE PT WAS ASYMPTOMATIC DURING THIS EVENT. THE LESION BEING TREATED WAS A 99% STENOTIC LESION IN THE MID LAD CORONARY ARTERY. THE PHYSICIAN USED A MEDIKIT INTRODUCER SHEATH FOR VASCULAR ACCESS AND A MACH1 GUIDE CATHETER TO CROSS THE LESION. AFTER CROSSING THE LESION USING THIS GUIDE WIRE, THE MAVERICK OTW BALLOON WAS INFLATED TO 6 ATMS AT THE LESION SITE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE MAVERICK OTW BALLOON, THE CHOICE PT PLUS GUIDEWIRE BECAME STUCK IN THE WIRE LUMEN OF THE BALLOON CATHETER. THE GUIDEWIRE AND BALLOON WERE REMOVED AS A UNIT. AFTER CROSSING THE LESION USING THIS CHOICE PT PLUS GUIDEWIRE AGAIN, A JLL BALLOON WAS INFLATED AT THE LESION SITE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE JLL BALLOON, THE CHOICE PT PLUS GUIDEWIRE BECAME STUCK IN THE WIRE LUMEN OF THAT BALLOON CATHETER ALSO. THE GUIDEWIRE AND BALLOON WERE REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS 'GOOD'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRES CHOICE PTCA GUIDEWIRE DQX BOSTON SCIENTIFIC CHOICE PT 6241701

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN