BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY GUIDEWIRE

    MDR report key: 1944862 · Received January 3, 2011

    Report

    Report Number
    2134265-2010-05693
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INTERVENTION TREATMENT PROCEDURE, A GUIDE WIRE TIP FRACTURE OCCURRED. THE PHYSICIAN WAS TREATING A 100% STENOSED, CHRONIC TOTAL OCCLUSION LESION LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN WAS ATTEMPTING TO NAVIGATE THIS 185CM JOURNEY GUIDE WIRE THROUGH THE OCCLUSION. RESISTANCE WAS MET AND THE GUIDE WIRE BECAME BURIED IN THE LESION CAUSING A PORTION OF THE TIP TO DETACH. THERE WAS NO ATTEMPT MADE TO RETRIEVE THE TIP. THE TIP DID NOT EMBOLIZE AND REMAINS IN THE LESION LOCATED IN THE RCA. THE PHYSICIAN BELIEVES THAT THE TIP REMAINS IN A LOCATION WHERE THE PATIENT IS NOT AT RISK. THE CASE WAS ENDED AT THIS POINT. THE PATIENT EXPERIENCED SLURRED SPEECH AND AN MRI CONFIRMED INFARCTIONS, HOWEVER, ETIOLOGY WAS UNCLEAR. SYMPTOMS RESOLVED WITHOUT TREATMENT PRIOR TO DISCHARGE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001391260 13780819

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other