PUMA-G System™ 0010210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00850026037043), received between Apr 14, 2022 and Jun 27, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2024Entrapment of Device; Difficult to Remove; Difficult to Advance; Entrapment of Device; Difficult to Remove; Difficult to Advance

  THE INITIAL STEPS OF THE PERCUTANEOUS ULTRASOUND GASTROSTOMY (PUG) PROCEDURE WERE COMPLETED TO ACHIEVE COUPLING BETWEEN THE PIGTAIL GUIDEWIRE (PGW) AND INTERNAL BALLOON CATHETER (IBC). AS THE COUPLED IBC-PGW WAS FED THROUGH THE OROGASTRIC TRACT, THE NASOGASTRIC TUBE (NGT) WAS REMOVED AS THE PRIMARY PROCEDURALIST THOUGHT IT WAS POTENTIALLY INTERFERING WITH THE IBC REMOVAL. ONCE OUTSIDE OF THE MOUTH, THE BALLOON WAS NOT COUPLED WITH THE PGW (I.E., THE PIGTAIL WAS NOT INSIDE THE BALLOON). A GLIDESCOPE WAS USED TO EXAMINE THE ORAL CAVITY AND PHARYNX BUT THE PGW WAS NOT FOUND. THE GUIDEWIRE WAS REMOVED FROM THE ABDOMINAL END, AND THE CLINICAL TEAM CHOSE TO CONTINUE WITH A SECOND KIT. AFTER IBC INSERTION, THE BALLOON WAS NOT VISUALIZED IMMEDIATELY. A NEW NGT WAS INSERTED FOR ADDITIONAL INSUFFLATION, AFTER WHICH THE BALLOON WAS VISUALIZED AGAIN AT 3CM TISSUE DEPTH. AGAIN, THE INITIAL STEPS OF THE PUG PROCEDURE WERE COMPLETED WITHOUT ISSUE, AND THE COUPLED IBC-PGW WAS ADVANCED THROUGH THE OROGASTRIC TRACT; THIS TIME BOTH WERE RETRIEVED THROUGH THE MOUTH. AFTER RETRIEVING ABOUT 15CM OF THE PGW OUT OF THE MOUTH, THE PROCEDURALIST FELT RESISTANCE AND WAS UNABLE TO CONTINUE ADVANCING THE GUIDE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19627573 ↗
• InjuryApr 24, 2024Use of Device Problem; Use of Device Problem

  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 DESCRIB

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19174725 ↗
• InjuryApr 5, 2024Inadequate or Insufficient Training; Improper or Incorrect Procedure or Method; Inadequate or Insufficient Training; Improper or Incorrect Procedure or Method

  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

  Patient problems: Bowel Perforation

  MAUDE report 19053183 ↗
• MalfunctionNov 30, 2023Difficult to Remove; Deformation Due to Compressive Stress; Insufficient Device Problem Information; Difficult to Remove; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  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 BLEEDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241693 ↗
• InjuryMar 22, 2023Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  DURING THE PERCUTANEOUS ULTRASOUND GASTROSTOMY (PUG) PROCEDURE, THE PROCEDURALIST PERFORMED THE STEPS TO ACHIEVE THROUGH-AND-THROUGH GUIDEWIRE ACCESS (I.E., GUIDEWIRE IS POSITIONED THROUGH THE OROGASTRIC TRACT EXITING AT THE MOUTH AND ABDOMINAL PUNCTURE SITE). THE USER NOTED THAT THE ABDOMINAL WALL THICKNESS WAS ABOUT 5 CM (ABOVE THE INDICATION OF 4.5 CM FOR THE PUMA-G SYSTEM) AND THAT PATIENT POSITIONING WAS CHALLENGING DURING THE PROCEDURE. THE FIRST GUIDEWIRE CUT WAS CONSIDERED UNSATISFACTORY (I.E., ENDS WERE NOT CLEAN CUTS), SO A SECOND CUT WAS PERFORMED, WHICH, UPON REVIEW, THE USER BELIEVES WAS LOCATED OUTSIDE AND DISTAL (AWAY FROM THE PIGTAIL) TO THE MARKED SECTION OF THE GUIDEWIRE INTENDED FOR CUTTING. OF NOTE, THE PUMA-G GUIDEWIRE IS CONSTRUCTED OF A CORE WIRE AND OUTER SPRING-COIL WIRE, WHICH, WHEN CUT OUTSIDE OF THE MARKED GLUED SECTION, CAN CAUSE THE SPRING-COIL WIRE TO UNRAVEL. THE G-TUBE WAS INSERTED THROUGH THE MOUTH AND FED OVER THE GUIDEWIRE THROUGH THE ESTABLISHED TRACT BUT HAD NOT YET EXISTED AT THE ABDOMINAL SITE WHEN THE USER NOTICED THAT THE GUIDEWIRE HAD SEPARATED. HE STOPPED THE PROCEDURE AND NOTIFIED A SURGEON, WHO ARRIVED WITHIN 30 MINUTES TO REMOVE THE SP

  Patient problems: Foreign Body In Patient

  MAUDE report 16595696 ↗
• InjuryApr 14, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  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 PERI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14111735 ↗