BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMA-G SYSTEM

    MDR report key: 18241693 · Received November 30, 2023

    Report

    Report Number
    3015177732-2023-00003
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    October 31, 2023
    Report Date
    November 30, 2023
    Manufacturer
    COAPTECH, INC.
    Product Code
    KGC
    UDI-DI
    00850026037043
    PMA / PMN Number
    K223916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PRE-PROCEDURE ULTRASOUND CHECK (BY PHASED ARRAY TRANSDUCER) SHOWED A 4CM TISSUE DEPTH FOR THE GASTROSTOMY. THE INITIAL STEPS OF THE PERCUTANEOUS ULTRASOUND GASTROSTOMY (PUG) PROCEDURE WERE COMPLETED TO ACHIEVE COUPLING BETWEEN THE PERCUTANEOUS GUIDEWIRE (PGW) AND INTERNAL BALLOON CATHETER (IBC) AND TO ADVANCE THE COUPLED PGW AND IBC OUT OF THE MOUTH. THE PGW WAS CUT TO REMOVE THE PIGTAIL END AND THEN FED INTO THE G-TUBE, BUT HALTED AFTER RESISTANCE WAS ENCOUNTERED PULLING THE GUIDEWIRE OUT OF THE MOUTH AFTER FEEDING ABOUT 10-15CM OF GUIDEWIRE INTO THE G-TUBE. THE GUIDEWIRE WAS REMOVED FROM THE G-TUBE AT THIS POINT TO TROUBLESHOOT THE ENCOUNTERED RESISTANCE. AT THE ABDOMINAL END, THE GUIDEWIRE WAS ABLE TO ADVANCE EASILY BUT WHEN PULLED BACK, RESISTANCE WAS MET AT A CERTAIN POINT OF SLACK REMOVAL. A GLIDESCOPE WAS USED TO VIEW THE GUIDEWIRE IN THE MOUTH AND UPPER THROAT, WHICH SHOWED NO APPARENT ISSUES. THE GUIDEWIRE WAS REMOVED FROM THE ABDOMINAL END USING CLAMPS FOR GRIP IN A SAFE ABORT, AT WHICH POINT, TWO KINKED AREAS OF THE GUIDEWIRE WERE OBSERVED (SEE FIGURE 1 BELOW). NO FURTHER COMPLICATIONS OR CLINICAL EFFECTS WERE REPORTED AS CONFIRMED BY A POST-PROCEDURAL X-RAY, NO BLEEDING, NORMAL GASTRIC SUCTIONING, AND NO CHANGE IN ORAL SECRETIONS. NO ISSUES WERE REPORTED IN THE WEEKS FOLLOWING THE CASE AS WELL. WHILE THIS CASE WAS DETERMINED TO NOT RESULT IN A SERIOUS INJURY, THE DEVICE MALFUNCTION OBSERVED IN THE CASE RESULTED IN INITIAL RESISTANCE REMOVING THE GUIDEWIRE. IF CLINICAL CIRCUMSTANCES WERE DIFFERENT AND THE MALFUNCTION WERE TO RECUR, THERE IS A POSSIBILITY THAT THE PROCEDURE WOULD NOT BE ABLE TO BE ABORTED WITHOUT FURTHER MEDICAL INTERVENTIONS. THEREFORE, THIS EVENT IS REPORTABLE DUE TO THE POSSIBILITY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503535 PUMA-G SYSTEM FEEDING TUBE PLACEMENT AID KGC COAPTECH, INC. 001021X 2023100901 00850026037043

    Patients

    Seq Age Sex Outcome Treatment
    1 Female GASTROSTOMY TUBE.