BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 MODERATE SUPPORT GUIDEWIRE

    MDR report key: 622958 · Received July 25, 2005

    Report

    Report Number
    6000130-2005-00383
    Event Type
    Injury
    Date Received
    July 25, 2005
    Date of Event
    June 30, 2005
    Report Date
    July 1, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA/STENTING TREATMENT PROCEDURE, THE PT2 MODERATE SUPPORT 185 CM GUIDEWIRE FRACTURED. THE PT WAS ASYMPTOMATIC DURING THIS EVENT. THE LESIONS BEING TREATED WERE 99% STENOTIC AND LOCATED IN THE RIGHT POSTERIOR DESCENDING (R-PDA) AND RIGHT POSTERIOR ATRIOVENTICULAR (R-PAV) CORONARY ARTERIES AND THE FEMORAL ARTERY. THE PHYSICIAN USED A 6F GUIDEWIRE TO THE R-PDA. HE SUCCESSFULLY DEPLOYED A CYPHER 2.5/18 MM STENT AFTER HAVING CARRIED OUT PREDILATATION WITH A VENTO 2.0/20 MM BALLOON. SUBSEQUENTLY, HE ADVANCED THE PT2 GUIDEWIRE TO THE R-PAV AND PERFORMED BALLOON DILATATION WITH A VOYAGER 1.5/15 MM BALLOON. THE PHYSICIAN PLANNED TO TREAT A FEMORAL LESION NEXT AND ADVANCED THE PT2 GUIDEWIRE TO THE FEMORAL ARTERY. HE ATTEMPTED TO ASPIRATE THE THROMBUS WITH A 6F THROMBUSTER DEVICE AND AT THAT TIME, NOTICED THAT ABOUT 40 CM OF THE TIP OF THE PT2 GUIDEWIRE WAS BROKEN OFF. HE SUCCESSFULLY RETRIEVED THIS FRACTURED PORTION WITH A SNARE. 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 PT2 MODERATE SUPPORT GUIDEWIRE PTCA GUIDEWIRE DQX BOSTON SCIENTIFIC PT2 MODERATE SUPPORT 185 CM STR 7442674

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention