BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMA-G SYSTEM

    MDR report key: 17790324 · Received September 21, 2023

    Report

    Report Number
    3015177732-2023-00002
    Event Type
    Death
    Date Received
    September 21, 2023
    Date of Event
    August 22, 2023
    Report Date
    September 20, 2023
    Manufacturer
    COAPTECH, INC.
    Product Code
    KGC
    PMA / PMN Number
    K183057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING ITEMS ARE NOTEWORTHY REGARDING THE PROCEDURE: 1. THIS CASE IS CONSIDERED AN OFF-LABEL USAGE OF THE DEVICE DUE TO THE PATIENT HAVING A >4.5 CM TRACT DEPTH. AT THIS DISTANCE, THE MAGNETIC PEXY IS SO WEAK THAT IT CAN BE EASILY KNOCKED OFF/BECOME UNATTRACTED JUST BY THE NEEDLE OR THE GUIDEWIRE. ALSO AT THIS DISTANCE, THE WIRE BECOMES LESS EASY TO PULL THROUGH THE TRACT WITH THE SNARED BALLOON DUE TO THE BUILT-UP FRICTION OF THE TISSUE. 2. THE TECHNICIAN ASSISTING IN THE CASE INCORRECTLY PRELOADED THE GUIDEWIRE IN THE FEEDER TIP AND HAD TO RESET IT THROUGH THE DISPENSER WHILE THE NEEDLE WAS HELD IN PLACE AFTER BALLOON PUNCTURE. 3. IT WAS NOTED THE WIRE WENT THROUGH THE GASTROCOLIC LIGAMENT, WHICH MAY HAVE DECREASED THE ABILITY OF THE WIRE TO MOVE AS FREELY AS IT TYPICALLY WOULD. 4. IT WAS REPORTED THAT THE PRIMARY CLINICIAN ADVANCED THE GUIDEWIRE WHILE SIMULTANEOUSLY RETRACTING THE BALLOON CATHETER FROM THE MOUTH (PER STEP 17 OF THE IFU) AT A 2:1 RATIO. THE DISTANCE MEASURED FROM THE MOUTH TO THE PUNCTURE SITE WAS 62 CM, SO IT IS EXPECTED THAT APPROXIMATELY TWO TIMES THAT (124 CM) OF WIRE WAS FED INTO THE PATIENT. HOWEVER, THE PIGTAIL WAS FOUND IN THE STOMACH, MEANING A MAJORITY OF THE LENGTH OF THE WIRE HAD COILED INSIDE THE PATIENT'S ABDOMINAL CAVITY AND/OR SUBCUTANEOUS TISSUES. IT IS REASONABLE TO BELIEVE THAT THE ROOT CAUSE OF THE COMPLAINT IS DUE TO THE FORMATION OF A KINK OR KINKS THAT PREVENTED THE EASY MOVEMENT OF THE GUIDEWIRE THROUGH THE SUBCUTANEOUS TISSUE, BUT IT IS INCONCLUSIVE HOW THE KINK ORIGINATED. SOME SUPPORTING INFORMATION THAT IS NOTEWORTHY: 1. THE GUIDEWIRE IS NOT EASILY KINKED. JUST SIMPLY BENDING THE GUIDEWIRE WITHOUT A MANDREL OR SIMILAR HARD TOOLING WILL NOT KINK IT. FOR EXAMPLE, ONE CANNOT KINK A WIRE SIMPLY BY BENDING IT WITH YOUR FINGERS. THEREFORE,THE POTENTIAL SCENARIO THAT THE GUIDEWIRE WAS KINKED OUTSIDE OF THE BODY WHEN THE GUIDEWIRE WAS BEING RESET BY THE TECHNICIAN IS CONSIDERED UNLIKELY. 2. A NEEDLE CAN KINK A WIRE IF IT IS FORCED AROUND THE SHARP POINT. THE OCCURRENCE OF SUCH AN EVENT IS NOT SUPPORTED BY THE FOLLOWING CASE FINDINGS: (1) THE NEEDLE POINT WOULD HAVE CREATED A SHARPER KINK AND (2) THE WIRE'S PIGTAIL WAS FOUND INTRAGASTRIC WITHOUT EVIDENCE THAT IT WAS HELD OR ANCHORED TO ANYTHING THAT MAY CAUSE RESISTANCE FOR THE KINK TO FORM. 3. A NEEDLE CAN ALSO KINK A WIRE IF IT IS RETRACTED FROM THE STOMACH AFTER THE PIGTAIL IS INSERTED, AND THEN REINSERTED INTO THE STOMACH BUT CREATING A DIFFERENT TRACT. THE OCCURRENCE OF SUCH AN EVENT IS NOT SUPPORTED BY THE FOLLOWING CASE FINDINGS: (1) THE NEEDLE POINT WOULD HAVE CREATED A SHARPER KINK AND (2) THE NEEDLE WAS NOT REPORTED TO HAVE BEEN RETRACTED FROM THE STOMACH AND THEN RE-INSERTED. 4. A SNARE OR FORCEPS COULD KINK A WIRE, BUT THIS, TOO, WAS NOT SUPPORTED BY THE CASE FINDINGS BECAUSE THE KINK WAS SO FAR AWAY FROM THE PIGTAIL, WHICH WAS THE PART OF THE WIRE THAT WAS SNARED. 5. THE BEND SEEN IN THE RECOVERED GUIDEWIRE FROM THE CASE IS REMINISCENT OF WHEN A WIRE IS BENT AROUND A SMALL DIAMETER. A SIMILAR BEND WAS CREATED IN THE LAB WHEN THE WIRE WAS TWISTED TIGHTLY AROUND A FORCEP AND THEN PULLED TIGHTLY. ALTHOUGH NO HARD TOOLING/MANDREL WAS PLACED AROUND THE BEND SITE, THE GASTROCOLIC LIGAMENT OR OMENTAL SCARE TISSUE COULD POTENTIALLY HAVE BEEN TOUGH ENOUGH IF THE WIRE WAS LOOPED AND PULLED TIGHT. ALTHOUGH NO CONFIRMATORY CONCLUSION CAN BE DRAWN FROM THE AVAILABLE INFORMATION, THE FOLLOWING SCENARIO IS A POSSIBILITY: THE NEEDLE PIERCED A LIGAMENT AND/OR OMENTAL SCAR TISSUE WHILE IT WAS BEING INSERTED INTO THE BALLOON. AFTER THE NEEDLE WAS REMOVED, GUIDEWIRE FEEDING WAS ATTEMPTED AND ASSUMED TO BE LEADING UP THE OROGASTRIC TRACT FOR EXIT AT THE MOUTH, BUT INSTEAD WAS BEING PINCHED BY HARD SCAR TISSUES AND FED INTO THE ABDOMINAL CAVITY, WHICH ALSO CAUSED SEPARATION FROM THE BALLOON. WHEN THE WIRE WAS ATTEMPTED TO BE REMOVED, IT MAY HAVE LOOPED AROUND A LIGAMENT OR WEB OF OMENTAL SCAR TISSUES AND FORMED A KINK FROM THE PULLING FORCE IN THE MULTIPLE ATTEMPTS TO ABORT THE PROCEDURE.

    Description of Event or Problem · 0

    DURING THE PERCUTANEOUS ULTRASOUND GASTROSTOMY (PUG) PROCEDURE, THE USER WAS UNABLE TO LOCATE AND VISUALIZE THE BALLOON INITIALLY. WITH COAPTECH SUPPORT, THE BALLOON WAS LOCATED AT A TRACT DEPTH BEYOND 4.5CM, WHICH IS HIGHER THAN OF THE INTENDED TRACT DEPTH FOR THE PUMA-G SYSTEM. THE BALLOON WAS TARGETED WITH THE 9CM NEEDLE AND BLUE FLASHBACK WAS SEEN, CONFIRMING BALLOON PUNCTURE. THERE WAS A SLIGHT PROCEDURAL DELAY AS THE PGW HAD TO BE RESET WITH THE PIGTAIL END INSIDE THE FEEDER TIP. THE PGW WAS THEN FED THROUGH THE NEEDLE AND THE USER CONFIRMED A DROP IN RESISTANCE, INDICATING THE PIGTAIL END EXITED THE NEEDLE. THE FEEDER TIP AND NEEDLE WERE REMOVED FROM THE PGW, AND THE BALLOON WAS DEFLATED. THE PGW WAS FED FURTHER INTO THE ABDOMINAL SITE AS THE CATHETER WAS PULLED OUT OF THE MOUTH. UPON EXIT FROM THE MOUTH, THE BALLOON DID NOT CONTAIN THE PGW. A LARYNGOSCOPE BLADE WAS USED BUT DID NOT LOCATE THE PGW. THE USER ATTEMPTED TO REMOVE THE PGW BY PULLING AT THE GASTROSTOMY SITE BUT FELT RESISTANCE. A BRONCHOSCOPE WAS THEN INSERTED TO VISUALIZE THE PGW AND CONFIRMED THAT THE PIGTAIL END OF THE PGW WAS INTRAGASTRIC. USING THE BRONCHOSCOPE, THE CLINICAL TEAM ATTEMPTED TO REMOVE THE PGW BY SNARING THE PIGTAIL, BUT RESISTANCE PREVENTED SIGNIFICANT MOVEMENT OF THE PGW. ENDOSCOPIC FORCEPS WERE ALSO USED IN AN ATTEMPT TO REMOVE THE PGW, BUT THE USER AGAIN ENCOUNTERED RESISTANCE AT A CERTAIN POINT, PREVENTING REMOVAL. AN X-RAY WAS ORDERED TO VISUALIZE THE PGW, REVEALING THAT THE GUIDEWIRE WAS KINKED WITHIN THE ABDOMINAL WALL. A GENERAL SURGEON ATTEMPTED TO REMOVE THE PGW USING FORCEPS VIA ESOPHAGOGASTRODUODENOSCOPY (EGD) BUT WAS UNABLE TO DO SO DUE TO RESISTANCE. GIVEN THE PGW WAS RETAINED, AND THE PATIENT HAD A HISTORY OF ABDOMINAL DISTENTION WHICH WAS EXACERBATED BY PERCUTANEOUS GASTROSTOMY, THE SURGEON PERFORMED AN EXPLORATORY LAPAROTOMY WHICH CONFIRMED A SAFE GASTROSTOMY TRACT AND NO VISCERAL AND/OR ORGAN DAMAGE. DURING THIS PROCEDURE, THE PGW WAS REMOVED, BUT REQUIRED EXCISING A PIECE OF OMENTAL TISSUE AND/OR GASTROCOLIC LIGAMENT THAT HAD STRANGULATED THE WIRE AND WAS FIXING IT IN PLACE JUST DISTAL TO THE KINK IN THE WIRE. SIGNIFICANT ABDOMINAL SCAR TISSUE WAS ALSO OBSERVED DURING THE LAPAROTOMY AND REPORTED AS "THE OMENTUM WAS NOTICED TO BE TETHERED TO THE PREVIOUS UMBILICAL HERNIA REPAIR." THE SURGEON PLACED A STAMM GASTROSTOMY THROUGH THE SITE OF THE GASTROSTOMY MADE BY THE PGW. THE COLON WAS "NOTED TO BE DILATED FROM THE CECUM TO THE DISTAL SIGMOID, NO MECHANICAL OBSTRUCTION WAS APPRECIATED, AND UNABLE TO BE PLACED BACK INTO THE ABDOMINAL CAVITY WITHOUT UNDUE PRESSURE." THEREFORE, THE PATIENT WAS UNABLE TO BE CLOSED DUE TO SIGNIFICANT ABDOMINAL DISTENSION AND HIS ABDOMEN WAS LEFT OPEN FOR SERIAL OR EXAMINATIONS. IN THE SUBSEQUENT WEEK, THE PATIENT WAS PUT ON DIALYSIS FOR RENAL FAILURE AND DEVELOPED SEPTIC SHOCK. MULTIPLE TRIPS WERE MADE TO THE OR IN ATTEMPT TO CLOSE THE WOUND BUT WERE UNSUCCESSFUL DUE TO PERSISTENT DILATED COLON. THE PATIENT DIED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584772 PUMA-G SYSTEM FEEDING TUBE PLACEMENT AID KGC COAPTECH, INC. 001021X

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| D GASTROSTOMY TUBE| TRACHEOSTOMY TUBE