BEUDAMED
    FDA Adverse Event Death Summary report: N

    SKATER¿ DRAINAGE CATHETER

    MDR report key: 8577640 · Received May 3, 2019

    Report

    Report Number
    1625425-2019-00120
    Event Type
    Death
    Date Received
    May 3, 2019
    Date of Event
    March 14, 2019
    Report Date
    April 5, 2019
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    GBQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER A PART NUMBER NOR A LOT NUMBER WERE PROVIDED, SO A REVIEW OF DEVICE BATCH RECORDS COULD NOT BE CONDUCTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE ARE NO INDICATIONS THAT THE DRAINAGE CATHETER DEVICE MALFUNCTIONED OR CAUSED THE EVENT. THE EVENT DESCRIPTION STATES THAT THE DRAINAGE CATHETER HAD AN "UNCOMPLICATED ADMISSION AND DRAINAGE WERE WELL-FUNCTIONING". ALSO, THE EVENT DESCRIPTION STATES "NO ONE KEEP POINT SO FAR THAT THIS IS CONTINGENT IN EQUIPMENT FAILURE." COMMUNICATION WITH ARGON'S DIRECTOR OF GLOBAL CLINICAL SERVICES AND PHYSICIAN EDUCATION STATED "IF THE PATIENT WENT INTO HEMORRHAGIC SHOCK AND CARDIAC FAILURE DUE TO HEMOTHORAX THAT WOULD MOST LIKELY BE CAUSED BY TRANSECTING THE INTERCOSTAL ARTERY DURING PLACEMENT OF THE SKATER DRAIN. THAT WOULD HAVE NOTHING TO DO WITH THE PRODUCT AND WOULD BE DUE TO PLACEMENT TECHNIQUE/ TECHNICAL ERROR." AS NO SAMPLE WAS RETURNED AND THE ROOT CAUSE COULD NOT BE DETERMINED, NO CORRECTIVE ACTION WILL BE TAKEN IN RESPONSE TO THIS COMPLAINT. ADDITIONALLY, IT IS LIKELY THAT THE EVENT WAS DUE TO PLACEMENT TECHNIQUE/ TECHNICAL ERROR (PER CLINICAL INPUT BASED ON THE PROVIDED EVENT DESCRIPTION).

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE (B)(6) ON (B)(6) 2019 DUE TO CLINICALLY IMPORTANT PLEURAL FLUID. USUAL PROCEDURE FOLLOWED. UNCOMPLICATED ADMISSION AND DRAINAGE WERE WELL-FUNCTIONING FOR THE PATIENT TO AUTOSEPARATE THIS. THIS BELL QUICKLY DISCOVERED AND ACTION TAKEN. THE PATIENT THEN WENT FAST IN SHOCK AND DIED DESPITE ATTEMPTED REVIVAL. SUPPOSED BLEEDING SHOCK DUE TO HEMATOTHORAX, BUT THIS IS NOT CONFIRMED. POLICE AND HEALTH INSPECTORATE NOTIFIED. RESULTS OF LEGAL AUTOPSY ARE NOT KNOWN. NO ONE KEEP POINT SO FAR THAT THIS IS CONTINGENT IN EQUIPMENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371350 SKATER¿ DRAINAGE CATHETER DRAINAGE CATHETERS GBQ ARGON MEDICAL DEVICES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death