BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 1004049 · Received February 27, 2008

    Report

    Report Number
    2134265-2008-00554
    Event Type
    Injury
    Date Received
    February 27, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE GUIDE WIRE HAS BEEN DISPOSED; 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A VESSEL DISSECTION OCCURRED. THE LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA), AND THERE WAS A "SHEPHERDS HOOK TAKE OFF." THE PT2 GUIDE WIRE DISSECTED THE RCA. THE PHYSICIAN THEN PLACED THREE TAXUS DRUG-ELUTING STENTS (UNKNOWN SIZE) AND TWO STENTS OF ANOTHER MANUFACTURER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED 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 SUPPORT, 185, STRAIGHT, 1-PACK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR 2 VISION STENTS (UNKNOWN SIZE)