BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-18 CONTROL WIRE

    MDR report key: 2220640 · Received August 23, 2011

    Report

    Report Number
    2134265-2011-03839
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K033742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    SAME CASE AS MDR ID# 2134265-2011-03838. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A GUIDE WIRE BECAME STUCK. THE PHYSICIAN COMMENTED THAT THE THRUWAY OR V-18 GUIDE WIRE HAS BECOME STUCK WITH THE ATLANTIS SR CATHETER SEVERAL TIMES. THE PROCEDURE OUTCOME IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-18 CONTROL WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA UNK525

    Patients

    Seq Age Sex Outcome Treatment
    1 DIAGNOSITC CATHETER, ATLANTIS SR