BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 1153080 · Received September 8, 2008

    Report

    Report Number
    2134265-2008-02562
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    February 8, 2006
    Report Date
    August 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE 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 PROD 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

    CLINICAL TRIAL. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) A GRADE D SPIRAL VESSEL DISSECTION OCCURRED PRE STENT PLACEMENT. THE TARGET LESION WAS A 3.5 X 15 MM TORTUOUS AND 95% STENOSED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). A PT2 GUIDE WIRE WAS ADVANCED AND RESISTANCE WAS REPORTED. THE PHYSICIAN STATED "IT WAS A CHALLENGING LESION" AND SUB-TOTALLY OCCLUDED. BASED ON ANGIOGRAPHY, THE PHYSICIAN FELT THE GUIDE WIRE CAUSED A VESSEL DISSECTION. THE TARGET LESION AND DISSECTION WERE TREATED WITH FOUR OVERLAPPING STENTS (THREE TAXUS LIBERTE AND ANOTHER MFR'S BARE METAL STENT). THE PT WAS DISCHARGED ONE DAY POST PROCEDURE WITH NO ADD'L REPORTED EVENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention