BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 1111884 · Received August 12, 2008

    Report

    Report Number
    2134265-2008-02304
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE LESIONS BEING TREATED WERE LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND PROXIMAL FIRST DIAGONAL (D1). ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY, AND FOLLOWING DIAGNOSTICS, AN 8FR INTRODUCER SHEATH WAS INSERTED. THE 185CM PT2 GUIDE WIRE WAS ADVANCED ACROSS THE LESION IN THE LAD, WITH A SECOND WIRE ADVANCED ACROSS THE LESION IN THE D1. A 3.0 X 16MM TAXUS EXPRESS2 DES STENT WAS DEPLOYED IN THE LAD LESION. A MAVERICK2 2.0X15MM BALLOON WAS ADVANCED TO THE SITE OF THE D1 LESION, INFLATED AND REMOVED. A 2.75 X 16MM TAXUS EXPRESS2 DES STENT WAS DEPLOYED IN THE D1 LESION SITE. A MAVERICK2 3.0 X 15MM BALLOON WAS ADVANCED IN THE STENT PREVIOUSLY DEPLOYED IN THE D1, AND THE 3.0 X 16MM TAXUS EXPRESS2 BALLOON WITHIN THE DEPLOYED STENT IN THE LAD AND THE MAVERICK 3.0X15MM WITHIN THE STENT IN THE DIAGONAL WERE INFLATED SIMULTANEOUSLY. THE DISTAL TIP OF THE PT2 GUIDE WIRE WAS NOTED TO BE DETACHED IN THE D1 BRANCH AFTER PULLING BACK THE GUIDE WIRE SLIGHTLY. THE GUIDE WIRE WAS REMOVED, AND A 300CM CHOICE PT MS GUIDE WIRE WAS INSERTED. A SNARE CATHETER WAS THEN ADVANCED AND MULTIPLE ATTEMPTS WERE MADE TO SNARE THE WIRE TIP WITH SUCCESS. FOLLOW UP VENTRICULOGRAPHY WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS REPORTED AS 'OKAY'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 GUIDE WIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC MODERATE, 185, J, 5-PACK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention