BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHOICE PT GRAPHIX GUIDEWIRE

    MDR report key: 1874342 · Received October 19, 2010

    Report

    Report Number
    2134265-2010-04616
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    K950835
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION BY MANUFACTURER: 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

    SAME CASE AS MFG # 2134265-2010-04550. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE COATING DAMAGE OCCURRED. THE 10MM LESION BEING TREATED WAS LOCATED IN THE NON CALCIFIED AND NON TORTUOUS POSTEROLATERAL DESCENDING BRANCH OF THE RIGHT CORONARY ARTERY (RCA). A PREVIOUSLY PLACED TAXUS LIBERTE STENT WAS PLACED PROXIMAL TO THAT LESION 2 WEEKS PRIOR. THE PATIENT EXPERIENCED CHEST PAIN, AND THE LESION IN THE RCA WAS DISCOVERED. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. A PT GRAPHIX GUIDE WIRE WAS UNABLE TO CROSS THE PREVIOUSLY PLACED TAXUS LIBERTE STENT AND WAS WITHDRAWN. ANOTHER UNSPECIFIED GUIDE WIRE WAS ADVANCED AND WOULD NOT CROSS THE STENT. ANOTHER CHOICE PT GRAPHIX GUIDE WIRE WAS ADVANCED, AND WHEN INSIDE THE STENT, THE GUIDE WIRE PROLAPSED. THE GUIDE WIRE WENT THROUGH THE STENT AND A STENT STRUT WAS LIFTED. THE WIRE WAS PULLED BACK, AND THE WIRE WAS STUCK. "THE WIRE WAS PULLED A LITTLE MORE," AND WAS WITHDRAWN. IT WAS OBSERVED THAT "SOME OF THE COATING WAS MISSING." X-RAY WAS OBTAINED AND "TWO PIECES REMAINED IN THE RIGHT VENTRICLE (RV) MARGINAL BRANCH. THE PIECES THEN MOVED DOWN THE VERY SMALL SIDE BRANCH" AND REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS DISCONTINUED. THE LESION WAS NOT TREATED. THE PATIENT IS TO BE SCHEDULED FOR AN ULTRASOUND TO DETERMINE THE COURSE OF ACTION. THE PATIENT'S STATUS IS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOICE PT GRAPHIX GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI H7491490201J1

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other JR4 GUIDE CATHETER