BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETIX PLUS PTCA GUIDEWIRE

    MDR report key: 1821673 · Received August 31, 2010

    Report

    Report Number
    2134265-2010-03779
    Event Type
    Injury
    Date Received
    August 31, 2010
    Report Date
    August 6, 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

    DEVICE EVALUATED BY MANUFACTURER: 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 DURING A PERIPHERAL INTERVENTION TIP DETACHMENT OCCURRED. WHILE ADVANCING THE KINETIX PLUS GUIDEWIRE TO THE PERONEAL ARTERY, THE DISTAL TIP OF THE GUIDEWIRE DETACHED FROM THE DEVICE. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY SNARE THE DETACHED TIP FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS FINE. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PLUS PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122032 13387698

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention