BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE CATHETER SYSTEM

    MDR report key: 5118176 · Received October 1, 2015

    Report

    Report Number
    3004962788-2015-00089
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Date of Event
    September 2, 2015
    Report Date
    December 1, 2015
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K102604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: 10/02/2015. DATE OF FOLLOW-UP REPORT: 12/01/2015. THE EXTENDED WORKING CHANNEL (EWC) WAS VERIFIED TO HAVE SCRAPE MARKS FROM THE USER'S BRONCHOSCOPE ON THE OUTER DIAMETER OF THE DISTAL END OF THE EWC.

    Additional Manufacturer Narrative · 1

    SUPERDIMENSION HAS REQUESTED THE DEVICE FOR EVALUATION BUT HAS NOT RECEIVED ANYTHING TO DATE. THE PHYSICIAN NOTED A BROKEN JAGGED EDGE INSIDE THE BRONCHOSCOPE THAT WAS SCRAPING THE OUTSIDE OF THE EWC. THERE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. SUPERDIMENSION IS FILING THIS MDR BECAUSE OF THE POSSIBLE OF DEBRIS BEING LEFT BEHIND IN THE PATIENT.

    Description of Event or Problem · 1

    THE SITE REPORTED SHAVINGS FROM THE EXTENDED WORKING CHANNELS (EWC) INSIDE THE BRONCHOSCOPE DURING A SUPERDIMENSION PROCEDURE. THERE WAS NO INJURY OR SERIOUS ADVERSE EVENT TO THE PATIENT AND THE PATIENT WAS RELEASED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650199 EDGE CATHETER SYSTEM GUIDE CATHETER JAK SUPERDIMENSION INC. 1925-5 EK04427

    Patients

    Seq Age Sex Outcome Treatment
    1