BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMA-G SYSTEM

    MDR report key: 14111735 · Received April 14, 2022

    Report

    Report Number
    3015177732-2022-00001
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    March 4, 2022
    Report Date
    March 11, 2022
    Manufacturer
    COAPTECH
    Product Code
    KGC
    UDI-DI
    00850026037043
    PMA / PMN Number
    K183057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INSUFFLATION WAS NOT PERFORMED PRIOR TO NEEDLE STICKS, AND THERE WERE MULTIPLE NEEDLE STICKS WHILE TRYING TO HIT THE BALLOON. INSUFFLATION IS RECOMMENDED IN ALL PERCUTANEOUS GASTROSTOMY METHODS FOR A VARIETY OF REASONS, BUT OF PARTICULAR RELEVANCE IN THIS CASE, INSUFFLATION AIDS IN AVOIDING THE VASCULAR STRUCTURES SURROUNDING THE STOMACH, PARTICULARLY IN THE POSTERIOR REGIONS. EVEN CONSIDERING THE PROCEDURAL DEVIATIONS, THERE WERE NO APPARENT CLINICAL CONCERNS FROM THE USE OF THE PUMA-G SYSTEM, BASED ON CONFIRMATION OF CORRECT PLACEMENT OF THE G-TUBE AND NO EVIDENCE OF ORGAN INJURY.

    Description of Event or Problem · 0

    ABDOMINAL HEMORRHAGE IN PERITONEAL CAVITY FOUND AND RESOLVED AFTER USING THE PUMA-G SYSTEM TO COMPLETE A PERCUTANEOUS ULTRASOUND GASTROSTOMY (PUG) PROCEDURE. A CHEST CT CONFIRMED THAT THE STOMACH WAS ANATOMICALLY WITHIN THE INDICATIONS FOR A PERCUTANEOUS ULTRASOUND GASTROSTOMY (PUG) PROCEDURE USING THE PUMA-G SYSTEM. DURING THE PUG PROCEDURE, THE PHYSICIAN VISUALIZED THE BALLOON, LOCATED SOMEWHAT UNDER THE RIBS, VIA ULTRASOUND, AND UNSUCCESSFULLY ATTEMPTED BALLOON PUNCTURE WITHOUT USING INSUFFLATION. AFTER LOSING VISUALIZATION, THE PHYSICIAN REMOVED AND REPLACED THE BALLOON IN THE STOMACH, ESTABLISHING A CLEAR VIEW OF THE BALLOON. APPROXIMATELY 5 OR 6 NEEDLE STICKS WERE ATTEMPTED BEFORE BALLOON PUNCTURE WAS CONFIRMED WITH BLUE ASPIRANT. THE REMAINDER OF THE PROCEDURE PROCEEDED WITHOUT ISSUE THROUGH GASTROSTOMY TUBE PLACEMENT. NO SIGNS OF BLEEDING WERE APPARENT AT THE TIME THE PROCEDURE CONCLUDED. WITHIN HOURS OF THE PROCEDURE, THE PATIENT BECAME UNSTABLE, INITIALLY TACHYPNEIC, AND THEN WENT INTO SHOCK WITH A BLEEDING COMPLICATION. A CT SHOWED BLOOD AROUND THE STOMACH AND THE G-TUBE IN AN ACCEPTABLE LOCATION. AN EXPLORATORY LAPAROTOMY WAS PERFORMED, REVEALING 2L OF BLOOD IN THE PERITONEUM. THE G-TUBE WAS LEFT IN PLACE WHILE THE BLOOD AND CLOTS WERE CLEANED OUT. SINCE THEN, THE PATIENT HAS HAD NO FURTHER COMPLICATIONS FROM THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190721 PUMA-G SYSTEM FEEDING TUBE PLACEMENT AID KGC COAPTECH 001021X 2022013101 00850026037043

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention GASTROSTOMY TUBE