BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHIOCE GUIDEWIRE

    MDR report key: 1911512 · Received December 1, 2010

    Report

    Report Number
    2134265-2010-05423
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K970244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED 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

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY TREATMENT PROCEDURE, A VESSEL PERFORATION OCCURRED. DURING AN ANGIOPLASTY PROCEDURE IT WAS REPORTED THAT "WHEN THE DOCTOR WAS USING THE CHOICE PT THE ARTERY IS DRILLED." "THE PATIENT "WAS IMPLANTED WITH TWO PROMUS ELEMENT STENTS, THEN WAS FOLLOWING WITH A SURGERY." THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHIOCE GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H7491216001J1

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention