BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 1062517 · Received June 18, 2008

    Report

    Report Number
    2134265-2008-01716
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 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 USER FACILITY HAS RETAINED THIS GUIDE WIRE, CONSEQUENTLY, A RETURNED PRODUCT ANALYSIS WILL NOT BE POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE LESION WAS LOCATED IN THE OBTUSE MARGINAL (OM) ARTERY. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE DISTAL TIP OF THE PT2 MODERATE SUPPORT GUIDE WIRE DETACHED AND "LANDED IN THE DISTAL OM". THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER PT2 GUIDE WIRE, HOWEVER, FOR UNSPECIFIED REASONS "DECIDED TO PULL IT ALL OUT AND ENDED THE CASE". THE DISTAL TIP REMAINS INSIDE THE PT AND THE PHYSICIAN HAS NO FURTHER PLANS TO ATTEMPT RETRIEVAL DURING A SUBSEQUENT PROCEDURE. THE PT'S STATUS IS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 GUIDE WIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC MODERATE, 185, STRAIGHT, 1-PACK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other