BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMA-G SYSTEM

    MDR report key: 14214863 · Received April 26, 2022

    Report

    Report Number
    3015177732-2022-00002
    Event Type
    Death
    Date Received
    April 26, 2022
    Date of Event
    August 3, 2020
    Report Date
    April 6, 2022
    Manufacturer
    COAPTECH
    Product Code
    KGC
    UDI-DI
    00860312001580
    PMA / PMN Number
    K183057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE THAT THIS CASE AND THE ASSOCIATED ADVERSE EVENTS WERE REVIEWED AS PART OF A RETROSPECTIVE STUDY IN PROGRESS AT THE (B)(6) MEDICAL CENTER ((B)(6)) AND (B)(6) MEDICAL CENTER ((B)(6)). THEREFORE, THE DATE OF OCCURRENCE IS MUCH EARLIER THAN THE DATE OF AWARENESS. IMMEDIATELY POST-PROCEDURE, THERE WERE NO APPARENT CLINICAL CONCERNS FROM THE USE OF THE PUMA-G SYSTEM AND NO EVIDENCE OF A BLEED. THERE WAS NO APPARENT DEVICE MISUSE OR MALFUNCTION.

    Description of Event or Problem · 0

    PUMA-G SYSTEM USED TO COMPLETE A PERCUTANEOUS ULTRASOUND GASTROSTOMY (PUG) PROCEDURE ON (B)(6) 2020 WITH NO ISSUES OR BLOODY OUTPUT FOUND. THE PATIENT WAS NOTED AS HEMODYNAMICALLY STABLE WITHOUT BLEEDING ON (B)(6) 2020 BUT REPORTING 2X SUPRA-THERAPEUTIC PARTIAL THROMBOPLASTIC TIMES (PTT) OF 205 (GOAL IS 70-90). ON (B)(6) 2020, THE PTT REMAINED ELEVATED 112-155 RANGES, THEN THE PATIENT EXPERIENCED A HEMOGLOBIN DROP, FOLLOWED BY MELENA AND LATER BRIGHT RED BLOOD PER RECTUM (BRBPR). WHILE PREPPING FOR A-LINE PLACEMENT, THE PATIENT'S HEART RATE DROPPED, THE PATIENT BECAME ASYSTOLIC AND THE PATIENT DIED APPROXIMATELY 48 HOURS POST-PROCEDURE WITH NO RESUSCITATION OR EXTRAORDINARY MEASURES TAKEN DUE TO DO NOT RESUSCITATE STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495368 PUMA-G SYSTEM FEEDING TUBE PLACEMENT AID KGC COAPTECH 0010112 726752 00860312001580

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| D GASTROSTOMY TUBE.| HEPARIN INFUSIONS.