BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY¿

    MDR report key: 2770671 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-05954
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 23, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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 PERIPHERAL TREATMENT PROCEDURE GUIDE WIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID ANTERIOR TIBIAL ARTERY. A JOURNEY GUIDE WIRE HAD BEEN SELECTED AND ADVANCED. DURING THE PROCEDURE, THE TIP OF THE GUIDE WIRE DETACHED. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DETACHED PORTION WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001391290

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention