BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETIX PTCA GUIDEWIRE

    MDR report key: 1910479 · Received November 30, 2010

    Report

    Report Number
    2134265-2010-05129
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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 PREPARATION OF THE GUIDE WIRE A TIP FRACTURE OCCURRED. AS THE PHYSICIAN SHAPED THE DISTAL TIP OF THE 300CM KINETIX GUIDE WIRE, THE NITINOL SLEEVE DETACHED. THIS EVENT OCCURRED OUTSIDE OF THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122020

    Patients

    Seq Age Sex Outcome Treatment
    1