BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMA-G SYSTEM

    MDR report key: 19053183 · Received April 5, 2024

    Report

    Report Number
    3015177732-2024-00001
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 4, 2024
    Manufacturer
    COAPTECH, INC.
    Product Code
    KGC
    UDI-DI
    00850026037081
    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

    THE BALLOON WAS VISUALIZED VIA ULTRASOUND UNDER THE PATIENT'S RIBS, WHICH MEANS THE IDENTIFIED NEEDLE TRACT WAS POSITIONED AT A SHALLOW ANGLE FROM THE ULTRASOUND PROBE. CONFIRMATORY FLUOROSCOPIC IMAGING OF A SAFE TRACT FOR THE NEEDLE WAS RECOMMENDED BY COAPTECH'S REPRESENTATIVES DUE TO THE BALLOON PLACEMENT UNDER THE PATIENT'S RIBS BUT REFUSED BY THE PROCEDURALIST. NOTE THAT THE PRODUCT IFU LISTS ABNORMAL UPPER GASTROINTESTINAL ANATOMY AS A CONTRAINDICATION AND DIRECTS THE USER TO HOLD THE HANDHELD MAGNET "BELOW THE RIBS" WHEN ACHIEVING COAPTATION WITH THE IBC. THE GUIDEWIRE WAS CAPTURED WITHIN THE BALLOON FOLLOWING NEEDLE ASPIRATION OF BLUE ASPIRANT AND THEN ADVANCED OUT OF THE MOUTH. THE G-TUBE WAS PLACED OVER THE GUIDEWIRE, AND RESISTANCE WAS ENCOUNTERED WHEN PULLING THE G-TUBE THROUGH THE SKIN EVEN WHEN A ROCKING METHOD WAS ATTEMPTED. THE RESISTANCE WAS BELIEVED TO BE RELATED TO SCARRING/ADHESIONS DUE TO THE PATIENT'S PRIOR SURGICAL HISTORY. THE SKIN NICK WAS INCREASED, AND DUE TO CONTINUED RESISTANCE, A DILATING CATHETER WAS PLACED OVER THE GUIDEWIRE ON THE PROXIMAL END. THE G-TUBE DILATING TIP WAS PULLED THROUGH USING A KELLY CLAMP, DURING WHICH A PART OF THE DILATOR TIP WAS PULLED OFF. THE CLAMP WAS RE-ATTACHED AND THE TUBE PULLED THROUGH MORE EASILY. THE G-TUBE BOLSTER WAS SECURED AT 4CM. AN X-RAY WAS CAPTURED POST-PROCEDURE THAT SHOWED NO CONCERNS. ON (B)(6) COAPTECH WAS INFORMED THAT 3 DAYS POST-PROCEDURE, THE PATIENT WAS EXPERIENCING INCREASED PAIN AT THE G-TUBE SITE. THE FOLLOWING DAY (4 DAYS POST-PROCEDURE) STOOL LEAKAGE WAS NOTED AND A CT OF THE ABDOMEN WAS OBTAINED, INDICATING THAT THE COLON WAS PUNCTURED VIA SUSPECTED SKIVING DURING NEEDLE INSERTION. ANTIBIOTICS WERE STARTED AND SURGERY WAS CONSULTED TO DETERMINE NEXT STEPS FOR THE PATIENT, BUT COAPTECH WAS NOT INFORMED OF ANY FURTHER CLINICAL EVENTS. WITHOUT ADDITIONAL INFORMATION, COAPTECH BELIEVES THE COLON SKIVING MAY HAVE OCCURRED IF THE FULL NEEDLE TRACT ZONE WAS NOT IMAGED WITH ULTRASOUND AND THEN THE NEEDLE WAS INSERTED OUT OF PLANE, CONSIDERING THE BALLOON WAS TARGETED UNDER THE RIBS. COAPTECH RECOMMENDS FULL TRACT IMAGING, ULTRASOUND OR OTHERWISE, PRIOR TO ESTABLISHING THE GASTROSTOMY TRACT.

    Description of Event or Problem · 0

    ON (B)(6) 2024 A COAPTECH REPRESENTATIVE WAS ON-SITE FOR A PERCUTANEOUS ULTRASOUND GASTROSTOMY (PUG) PROCEDURE AT NYP CORNELL MEDICAL CENTER THAT APPEARED SUCCESSFUL. THE PATIENT HAD A KNOWN CLINICAL HISTORY OF ABDOMINAL SURGERIES, FURTHER VERIFIED BY VISIBLE ABDOMINAL SCAR TISSUE, AND THE PUG WAS PERFORMED DESPITE CONCERNS FOR ABNORMAL UPPER GI ANATOMY AND THE LOCATION OF THE STOMACH AND BALLOON UNDER THE PATIENT'S RIBS, BOTH OF WHICH ARE WARNED ABOUT IN THE PUMA-G SYSTEM IFU. RESISTANCE WAS ENCOUNTERED DURING G-TUBE INSERTION, SO A DILATING CATHETER AND CLAMP WERE USED TO HELP PULL IT THROUGH AT THE ABDOMINAL SITE. AN X-RAY WAS CAPTURED POST-PROCEDURE THAT SHOWED NO CONCERNS, AND NO INDICATION OF DEVICE MALFUNCTION OR DEFECT NOR ANY PROCEDURAL ISSUES WITH THE PUMA-G SYSTEM WERE NOTED. ON (B)(6) 2024 COAPTECH WAS NOTIFIED BY HOSPITAL STAFF THAT THE PATIENT HAD EXPERIENCED STOOL LEAKAGE AT THE G-TUBE SITE AND SUBSEQUENTLY RECEIVED A CT OF THE ABDOMEN WHICH REVEALED A GASTROSTOMY TUBE SKIVING THROUGH THE COLON. THE PATIENT WAS STARTED ON ANTIBIOTICS AND WAS BEING OBSERVED CLINICALLY, WITH THE POSSIBILITY OF NEEDING ABDOMINAL SURGERY IF NO IMPROVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED. A SUSPECTED COLON PUNCTURE COULD CAUSE PERMANENT IMPAIRMENT OF A BODY FUNCTION IF NOT TREATED BY MEDICAL OR SURGICAL INTERVENTION, AND THEREFORE, CONSTITUTES A SERIOUS INJURY. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS BEING OBSERVED CLINICALLY IN CASE THERE WAS A NEED FOR SURGERY ON THE COLON. COLON PERFORATION IS A KNOWN COMPLICATION OF PERCUTANEOUS GASTROSTOMY IF THE TRACT IS NOT PROPERLY IDENTIFIED AND IMAGED FOR INTERFERING ANATOMY. OF NOTE, THE USER DID NOT ENGAGE IN TRAINING THAT IS STRONGLY RECOMMENDED BY COAPTECH PRIOR TO USING THE DEVICE, AND WARNINGS WITHIN THE PRODUCT INFORMATION WERE DISREGARDED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729801 PUMA-G SYSTEM FEEDING TUBE PLACEMENT AID KGC COAPTECH, INC. 001021X 2024011601 00850026037081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GASTROSTOMY TUBE