BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM SILICONE THORACIC CATHETER 28 FRENCH

    MDR report key: 7809474 · Received August 22, 2018

    Report

    Report Number
    MW5079347
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    November 19, 2017
    Report Date
    August 21, 2018
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    GBS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROVIDER REVIEWED THE PT'S RADIATION TREATMENT PLAN AND PLANNING CT ON TUESDAY, (B)(6), NOTICING WHAT APPEARED TO BE A SEGMENT OF A CHEST TUBE AT THE APEX OF THE LEFT LUNG. TWO CHEST TUBES WERE PLACED AND THESE WERE SEEN ON POST-SURGICAL CHEST X-RAYS DATED (B)(6) 2017. THE PT WAS DISCHARGED ON (B)(6) 2017. ANOTHER CHEST X-RAY WAS PERFORMED ON (B)(6) 2017, PRIOR TO A F/U APPT WITH A PROVIDER. THE REPORT NARRATIVE DESCRIBES A 16 CM TUBE IN THE "RIGHT UPPER LUNG FIELD" (THIS IS INCORRECT AND SHOULD BE "LEFT UPPER LUNG FIELD") WHILE THE IMPRESSION STATES "APPEARANCE OF A RETAINED 16 CM CHEST TUBE FRAGMENT AT THE LEFT UPPER ANTERIOR PLEURAL SPACE." PT WAS NOT HAVING ANY PROBLEMS RELATED TO THIS. AT TIME OF SURGERY, DECISION WAS MADE ON SURGEON TO LEAVE CHEST TUBE FRAGMENT IN LUNG FOR SAFETY OF PT AS REMOVING IT COULD CAUSE MORE HARM. PT WITH NEW DIAGNOSIS OF LEFT UPPER LUG ADENOCARCINOMA ADMITTED TO HOSP FOR THORACOTOMY ON (B)(6) 2017. PROCEDURE WAS ABORTED DUE TO SIZE OF TUMOR AND THE FACT IT ADHERED TO THE LUNG REQUIRING A LOBECTOMY FOR FULL REMOVAL (WHICH THE PT WOULDN'T TOLERATE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645634 AXIOM SILICONE THORACIC CATHETER 28 FRENCH CATHETER, VENTRICULAR, GENERAL AND PLASTIC SURGERY GBS AXIOM MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR