BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 2001159 · Received February 24, 2011

    Report

    Report Number
    2134265-2011-00536
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE GUIDE WIRE TIP DETACHMENT OCCURRED. THE 100% CHRONICALLY STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A PT2 MODERATE SUPPORT 185CM STR GUIDE WIRE WAS ABLE TO CROSS THE LESION AND TWO STENTS WERE SUCCESSFULLY PLACED. NEXT THE PHYSICIAN ATTEMPTED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD), WHEN IT WAS DISCOVERED THAT APPROXIMATELY 20MM OF THE PT2 WIRE TIP HAD DETACHED AND WAS STUCK IN THE PROXIMAL STENT LOCATED IN THE MID RCA. IT WAS NOTED THAT THE GUIDE WIRE WAS NEVER TRAPPED AND NO FRICTION WAS ENCOUNTERED UPON REMOVAL. ATTEMPTS TO RETRIEVE THE WIRE FRAGMENT WITH A MICRO RETRIEVER WERE UNSUCCESSFUL. ANOTHER STENT WAS IMPLANTED IN THE PROXIMAL STENT TO TRAP THE GUIDE WIRE TIP AGAINST THE STENT STRUTS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H74938931030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention