BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT GRAPHIX GUIDEWIRE

    MDR report key: 1935548 · Received December 22, 2010

    Report

    Report Number
    2134265-2010-05766
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K950835
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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 INTERVENTIONAL PROCEDURE THE TIP OF THE GUIDE WIRE BROKE OFF INSIDE THE PATIENT. THE HIGHLY STENOSED TARGET LESION THAT CONTAINED "HARD" PLAQUE WAS LOCATED IN THE RIGHT CORONARY ARTERY. A CHOICE PT GRAPHIX INTERMEDIATE WIRE WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION AND THE TIP OF THE GUIDE WIRE BROKE. NO ATTEMPTS TO RETRIEVE THE TIP WERE PERFORMED AS THE AMOUNT OF WIRE THAT DETACHED AND REMAINED INSIDE THE PATIENT WAS CONSIDERED TO BE "MINISCULE". NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE AND STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT GRAPHIX GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA UNK506

    Patients

    Seq Age Sex Outcome Treatment
    1 Other