BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 1033223 · Received April 16, 2008

    Report

    Report Number
    2134265-2008-01116
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE GUIDE WIRE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SELECTIVE PERIPHERAL ANGIOGRAPHY/SELECTIVE ILIAC PTA PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AN 8FR GUIDE CATHETER WAS USED TO ACCESS THE RIGHT COMMON ILIAC ARTERY. THE LESION WAS WIRED WITH THE PT2 GUIDE WIRE WITHOUT INCIDENT. THE PHYSICIAN "ANTICIPATED DIFFICULTY IN SUPPORT FROM THIS WIRE" AND ELECTED TO EXCHANGE THE PT2 (MODERATE SUPPORT) GUIDE WIRE FOR A "HEAVIER" GUIDE GUIDE WIRE. UPON REMOVAL OF THE PT2 GUIDE WIRE FROM THE RIGHT SFA, THE GUIDE WIRE FRACTURED. THE FRACTURED PORTION WAS LOCATED IN A SECURE LOCATION AND POSED NO RISK OF FURTHER EMBOLIZATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THREE DAYS POST PROCEDURE, A RIGHT AORTOBIFEMORAL BYPASS WAS PERFORMED TO REMOVE THE FOREIGN BODY. "THE WIRE WAS EASILY REMOVED, CAME OUT IN ITS ENTIRETY AND THERE WAS NO RESISTANCE MET". PATIENT STATUS IS "UNKNOWN". ACCORDING TO THE VASCULAR SURGEON WHO REMOVE THE GUIDE WIRE, THE "WIRE SHOWED NO EVIDENCE FOR OBVIOUS TRAUMA, NO KINKING, COILING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 GUIDE WIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC MODERATE, 300, J,1-PACK 11240838

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| O| R MICROGLIDE CATHETER| 8FR GUIDE CATHETER| FRONTRUNNER XP CTO CATHETER