BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMA-G SYSTEM

    MDR report key: 19174725 · Received April 24, 2024

    Report

    Report Number
    3015177732-2024-00002
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    April 2, 2024
    Report Date
    April 23, 2024
    Manufacturer
    COAPTECH, INC.
    Product Code
    KGC
    UDI-DI
    00850026037043
    PMA / PMN Number
    K223916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH A VESSEL BLEED IS NOT TYPICALLY A LIFE-THREATENING INJURY THAT RESULTS IN PERMANENT IMPAIRMENT OR DAMAGE, THIS CASE RESULTED IN SIGNIFICANT HEMORRHAGE REQUIRING SURGERY. THE EXPLORATORY LAPAROTOMY WAS NECESSARY TO PREVENT FURTHER DAMAGE FROM THE INTERNAL BLEEDING, AS WELL AS TO CONFIRM THAT NO OTHER SERIOUS INJURIES EXISTED. BECAUSE THIS EVENT NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, COAPTECH BELIEVES IT MEETS THE DEFINITION OF A SERIOUS INJURY.

    Description of Event or Problem · 0

    A PUG PROCEDURE WAS PERFORMED ON (B)(6) 2024 USING THE PUMA-G SYSTEM. THE PATIENT'S ABDOMEN WAS DESCRIBED AS BENIGN, AND THE BALLOON WAS VISUALIZED CLEARLY UNDER ULTRASOUND AT ABOUT A 4CM TRACT DEPTH. THE BALLOON WAS MOVED LEFT TO AVOID LIVER MARGIN VISUALIZED ON THE PATIENT'S RIGHT SIDE. THE PRIMARY PROCEDURALIST ATTEMPTED TO PUNCTURE THE BALLOON WITH THE NEEDLE 5 TIMES WITHOUT SUCCESS. ANOTHER PROCEDURALIST THEN ATTEMPTED THE NEEDLE PUNCTURE AFTER SHIFTING FURTHER LEFT. THE SIXTH PUNCTURE ASPIRATED FRANK BLOOD, AFTER WHICH THE CASE WAS ABORTED DUE TO BLEEDING CONCERNS. OF NOTE, COAPTECH DOES NOT RECOMMEND MULTIPLE PUNCTURE ATTEMPTS, ADVISING NO MORE THAN THREE PRIOR TO ABORTING IN PRODUCT TRAINING. THE PATIENT RECEIVED CT CONTRAST THAT SHOWED A LARGE QUANTITY OF BLOOD INSIDE THE ABDOMEN AND WAS STARTED ON PRESSORS. A BLOOD TRANSFUSION WAS PROVIDED AND EXPLORATORY LAPAROTOMY WAS PERFORMED TO STOP THE BLEEDING, REVEALING A BLOOD IN THE ABDOMEN. THE OPERATING SURGEON COMMENTED THAT THE BLEEDING ORIGINATED FROM A SMALL VESSEL ON THE OMENTUM. THERE WERE NO OTHER SIGNS OF NEEDLE TRAUMA NOR ERRANT NEEDLE PLACEMENT. A SURGICAL G-TUBE WAS PLACED DURING THE SURGERY. THE PATIENT WAS DESCRIBED AS RECOVERED AT THE TIME OF NOTIFICATION. NO DEVICE MALFUNCTION NOR ORGAN INJURY WAS REPORTED. BLEEDING IS A KNOWN COMPLICATION THAT IS LISTED IN THE PRODUCT IFU, AND THE SAME INJURY COULD HAVE OCCURRED WITH ANY PERCUTANEOUS APPROACH TO G-TUBE PLACEMENT (E.G., PEG OR PRG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190143 PUMA-G SYSTEM FEEDING TUBE PLACEMENT AID KGC COAPTECH, INC. 001021X 2023121201 00850026037043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention