BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETIX? PLUS

    MDR report key: 3875361 · Received June 16, 2014

    Report

    Report Number
    2134265-2014-03333
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 A TIP DETACHMENT OCCURRED. THE TARGET LESION IS UNKNOWN. A KINETIX¿ PLUS GUIDEWIRE WAS ADVANCED WHEN IT WAS NOTED THAT THE TIP OF THE WIRE BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE THE TIP THROUGH SNARING AND PROCEEDED WITH THE INTERVENTION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352739 KINETIX? PLUS WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122042 15763307

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention