OBALON® Balloon Kit HPMC 7600-0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00859810006067), received between Jan 10, 2018 and Apr 1, 2020 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2020Leak/Splash; Migration; Leak/Splash; Migration

  ONLY TWO INFLATED BALLOONS WERE IDENTIFIED IN THE STOMACH DURING A SCHEDULED 6-MONTH ENDOSCOPIC REMOVAL ON (B)(6) 2020 FOR A PATIENT WITH THREE BALLOONS IMPLANTED. A CT SCAN ON (B)(6) 2020 SHOWED NO FOREIGN BODY IDENTIFIED IN THE PATIENT THEREFORE THE PATIENT LIKELY PASSED THE MISSING BALLOON. THE PATIENT DID NOT REPORT ANY SYMPTOMS OR IDENTIFY THE BALLOON THAT PASSED. THE TWO INFLATED BALLOONS IN THE STOMACH WERE RETURNED TO OBALON FOR INVESTIGATION AND IT WAS CONFIRMED THROUGH LOT TRACING OF THE BALLOON VALVE THAT THE THIRD BALLOON ADMINISTERED WAS THE MISSING BALLOON. THE MISSING BALLOON WAS THE THIRD BALLOON WHICH WAS ADMINISTERED ON (B)(6) 2019 USING THE EZFILL DISPENSER AND THE ADMINISTRATION RECORD DOCUMENTED THE FINAL BALLOON PRESSURE AS 4.4 KPA WHICH IS WELL BELOW THE LABELED FINAL BALLOON PRESSURE PER THE INSTRUCTIONS FOR USE. DURING THE INVESTIGATION THE ADMINISTERING PHYSICIAN NOTED THAT THE BALLOON WAS INITIALLY INFLATED UP TO THE APPROPRIATE PRESSURE; HOWEVER, IT DID NOT STABILIZE IN THE PROPER PRESSURE RANGE DURING THE 30 SECOND LEAK CHECK, AND SUBSEQUENTLY HAD DROPPED TO 4.4 KPA. THE 1ST AND 2ND BALLOONS WERE INFLATED WITH STABLE INFLATION PRESSURES OF 12.3 KPA AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914581 ↗
• InjuryFeb 11, 2020Leak/Splash; Migration; Leak/Splash; Migration

  A SINGLE BALLOON MIGRATED INTO THE SMALL BOWEL CAUSING A PERFORATION AND REQUIRED SURGICAL REPAIR IN A PATIENT WITH THREE BALLOONS PLACED. THE PATIENT'S FIRST BALLOON WAS PLACED APPROXIMATELY 1.5 YEARS PRIOR ON (B)(6) 2018, THE SECOND BALLOON WAS PLACED ON (B)(6) 2018, AND THE THIRD BALLOON WAS PLACED ON (B)(6) 2018. THE PHYSICIAN HAD CONTACTED THE PATIENT MULTIPLE TIMES TO ATTEMPT SCHEDULING THE REMOVAL OF THE BALLOONS. THE PATIENT BEGAN EXPERIENCING SYMPTOMS OF ABDOMINAL PAIN AND PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2020 AND A CT SCAN SHOWED A BALLOON IN THE SMALL BOWEL. TWO INFLATED BALLOONS IN THE STOMACH WERE REMOVED ENDOSCOPICALLY ON (B)(6) 2020 AND THE MIGRATED BALLOON WAS IN THE MID JEJUNUM AND IT WAS FELT THAT THIS BALLOON WOULD LIKELY PASS. THE THIRD BALLOON REMAINED IN THE SMALL INTESTINE AND DURING THE HOSPITALIZATION THE PATIENT DEVELOPED WORSENING ABDOMINAL PAIN AND A CT SCAN SHOWED A SMALL BOWEL PERFORATION WITH INTRA-ABDOMINAL FREE AIR. THE MIGRATED BALLOON WAS SURGICALLY REMOVED AND A SMALL BOWEL RESECTION WAS PERFORMED ON (B)(6) 2020. THE PATIENT WAS HOSPITALIZED A TOTAL OF NINE DAYS AND WAS STABLE AFTER DISCHARGE. THE BALLOONS WERE NOT RETURNED TO OBAL

  Patient problems: Abdominal Pain

  MAUDE report 9696626 ↗
• MalfunctionNov 8, 2019Leak/Splash; Leak/Splash

  DURING A SCHEDULED ENDOSCOPIC REMOVAL PROCEDURE ON (B)(6) 2019, TWO BALLOONS WERE FOUND INFLATED AND ONE BALLOON WAS FOUND PARTIALLY DEFLATED FLOATING IN THE STOMACH. ALL BALLOONS WERE SUCCESSFULLY REMOVED BY ENDOSCOPY AND WERE RETURNED FOR INVESTIGATION. THE PATIENT DID NOT REPORT A NEW ONSET OF SYMPTOMS TO THEIR PRESCRIBING PHYSICIAN AND HAD THE FIRST BALLOON PLACEMENT ON (B)(6) 2019, SECOND BALLOON PLACEMENT ON (B)(6) 2019, AND THIRD BALLOON PLACEMENT ON (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9296315 ↗
• MalfunctionMay 8, 2019Leak/Splash; Leak/Splash

  A SINGLE BALLOON WAS FOUND TO BE NO LONGER LOCATED IN THE STOMACH DURING A SCHEDULED ENDOSCOPIC REMOVAL ON (B)(6) 2019 IN A PATIENT WITH TWO BALLOONS, FIRST BALLOON PLACEMENT OF (B)(6) 2018 AND SECOND BALLOON PLACEMENT OF (B)(6) 2018. THE REMAINING BALLOON LOCATED IN THE STOMACH WAS SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION BUT WAS NOT RETURNED FOR INVESTIGATION. AFTER THE DISCOVERY OF THE MISSING BALLOON AT REMOVAL, THE PATIENT NAUSEA AND VOMITING DURING LATE NOVEMBER OR EARLY DECEMBER THAT WAS NOT REPORTED TO THE PRESCRIBING PHYSICIAN. THE PATIENT RECEIVED AN ABDOMINAL RADIOGRAPHY ON (B)(6) 2019 THAT SHOWED NO SIGNS OF A BALLOON LOCATED IN THE INTESTINAL TRACT.

  Patient problems: Nausea; Vomiting

  MAUDE report 8591810 ↗
• MalfunctionMay 8, 2019Leak/Splash; Leak/Splash

  A SINGLE BALLOON WAS FOUND TO BE NO LONGER LOCATED IN THE STOMACH DURING A SCHEDULED ENDOSCOPIC REMOVAL ON (B)(6) 2019 IN A PATIENT WITH THREE BALLOONS, FIRST BALLOON PLACEMENT ON (B)(6) 2018, SECOND BALLOON PLACEMENT ON (B)(6) 2018, AND THIRD BALLOON PLACEMENT ON (B)(6) 2018. THE REMAINING BALLOONS LOCATED IN THE STOMACH WERE SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION BUT WERE NOT RETURNED FOR INVESTIGATION. THE PATIENT RECEIVED AN ABDOMINAL X-RAY ON (B)(6) 2019 THAT SHOWED NO SIGNS OF A DEFLATED BALLOON LOCATED IN THE INTESTINAL TRACT. THE PATIENT DID NOT EXPERIENCE SYMPTOMS CONSISTENT WITH BOWEL OBSTRUCTION OR REPORT A NEW ONSET OF SYMPTOMS TO THEIR PRESCRIBING PHYSICIAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8591342 ↗
• MalfunctionApr 24, 2019Leak/Splash; Leak/Splash

  A PATIENT WITH A FIRST BALLOON PLACEMENT OF (B)(6) 2018, SECOND BALLOON PLACEMENT OF (B)(6) 2018, AND THIRD BALLOON PLACEMENT OF (B)(6) 2018 HAD A REMOVAL SCHEDULED ON (B)(6) 2019 BUT CONTACTED THEIR PRESCRIBING PHYSICIAN'S OFFICE ON (B)(6) 2019 TO REQUEST AN EARLIER BALLOON REMOVAL. ON (B)(6) 2019 THE PATIENT REPORTED EXPERIENCING SEVERE ABDOMINAL PAIN AND THE PATIENT WAS INSTRUCTED GO TO THE ED IF THE PAIN WAS SEVERE, HOWEVER, THE PATIENT REQUESTED MEDICATIONS AND DECLINED TO GO TO THE ED. THE ENDOSCOPIC REMOVAL WAS SCHEDULED FOR (B)(6) 2019. DURING RETRIEVAL, ONE BALLOON WAS IDENTIFIED AS DEFLATED IN THE STOMACH AND MULTIPLE SUPERFICIAL NON-BLEEDING ULCERS RANGING IN SIZE FROM 10 TO 15 MM AND ERYTHEMA COMPATIBLE WITH GASTRITIS WERE FOUND IN THE ANTRUM. ALL BALLOONS WERE SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION AND WERE RETURNED FOR INVESTIGATION.

  Patient problems: Abdominal Pain; Ulcer

  MAUDE report 8547183 ↗
• MalfunctionMar 22, 2019Leak/Splash; Leak/Splash

  A SINGLE DEFLATED BALLOON WAS IDENTIFIED IN A PATIENT AFTER APPROXIMATELY 5 MONTHS FROM THE FIRST BALLOON PLACEMENT DURING A CT SCAN FOR REASONS NOT INVOLVING THE BALLOONS. IT IS UNKNOWN IF THE PATIENT EXPERIENCED SYMPTOMS RELATED TO THE BALLOON DEFLATION. THE DEFLATED BALLOON WAS IDENTIFIED AS LOCATED IN THE PYLORIC AREA OF THE STOMACH WITH NO MIGRATION INTO THE LOWER INTESTINE DURING ENDOSCOPIC REMOVAL ON (B)(6) 2019. ALL BALLOONS WERE SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION AND AN ULCER WAS IDENTIFIED IN THE STOMACH DURING THE REMOVAL. THE BALLOONS WERE RETURNED FOR INVESTIGATION.

  Patient problems: Abdominal Pain; Nausea; Ulcer; Vomiting

  MAUDE report 8444763 ↗
• MalfunctionMar 5, 2019Leak/Splash; Leak/Splash

  A SINGLE DEFLATED BALLOON WAS IDENTIFIED AT A SCHEDULED OVERDUE ENDOSCOPIC REMOVAL IN A MALE PATIENT WITH A FIRST BALLOON PLACEMENT OF (B)(6) 2018 AND SECOND BALLOON PLACEMENT OF (B)(6) 2018. THE BALLOON WAS IDENTIFIED FREE FLOATING IN THE STOMACH WITH NO MIGRATION INTO THE LOWER INTESTINE DURING THE NON-EMERGENT, SCHEDULED ENDOSCOPY REMOVAL ON (B)(6) 2019. ALL BALLOONS WERE SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION AND THE BALLOONS WERE NOT RETURNED FOR INVESTIGATION.

  Patient problems: No Information

  MAUDE report 8391252 ↗
• MalfunctionFeb 22, 2019Leak/Splash; Leak/Splash

  A SINGLE BALLOON WAS FOUND TO BE NO LONGER LOCATED IN THE STOMACH DURING A SCHEDULED OVERDUE ENDOSCOPIC REMOVAL ON (B)(6) 2019 IN A MALE PATIENT WITH A FIRST BALLOON PLACEMENT OF (B)(6) 2018, SECOND BALLOON PLACEMENT OF (B)(6) 2018, AND A THIRD BALLOON PLACEMENT OF (B)(6) 2018. THE TWO BALLOONS FOUND IN THE STOMACH WERE SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION BUT WERE NOT RETURNED TO OBALON FOR INVESTIGATION. THE PATIENT DID NOT REPORT A NEW ONSET OF SYMPTOMS TO THEIR PRESCRIBING PHYSICIAN, HOWEVER AFTER THE REMOVAL THE PATIENT STATED THEY HAD BLOATING AND FLATULENCE AT UNSPECIFIED DATES. THE PATIENT WAS INSTRUCTED BY THE PRESCRIBING PHYSICIAN AFTER THE BALLOON REMOVAL TO RECEIVE AN ABDOMINAL X-RAY, HOWEVER, TO DATE IT IS UNKNOWN IF THE PATIENT HAS RECEIVED AN X-RAY.

  Patient problems: Abdominal Distention; Flatus

  MAUDE report 8362437 ↗
• MalfunctionFeb 8, 2019Leak/Splash; Leak/Splash

  ON (B)(6) 2019 A SINGLE DEFLATED BALLOON WAS PASSED BY A FEMALE PATIENT WITH A FIRST BALLOON PLACEMENT OF (B)(6) 2018, SECOND BALLOON PLACEMENT OF (B)(6) 2018, AND THIRD BALLOON PLACEMENT OF (B)(6) 2018. THE PATIENT HAD CONTACTED THEIR PRESCRIBING PHYSICIAN WITH A NEW ONSET OF SYMPTOMS OF DAILY VOMITING BETWEEN (B)(6) 2018 BUT WAS NOT EVALUATED BY THE PRESCRIBING PHYSICIAN'S OFFICE AND INSTEAD WAS EXAMINED BY X-RAY AT A LOCAL HOSPITAL ON (B)(6) 2018. THE RADIOGRAPHY REPORT IDENTIFIED 3 FULLY INFLATED BALLOONS IN THE STOMACH HOWEVER THE PRESCRIBING PHYSICIAN ONLY RECEIVED THE RADIOGRAPHY REPORT AND DID NOT RECEIVE THE RADIOGRAPHIC IMAGES TO REVIEW. THE PATIENT WAS PREVIOUSLY SCHEDULED FOR THE ROUTINE ENDOSCOPIC REMOVAL ON (B)(6) 2019. AFTER THE PATIENT PASSED THE BALLOON ON (B)(6) 2019, THE PHYSICIAN PREFERRED TO REMOVE THE OTHER BALLOONS AS SOON AS POSSIBLE AND GAVE THE PATIENT THE OPTION TO HAVE THE BALLOONS REMOVED ON (B)(6) 2019 OR TO KEEP THEIR SCHEDULED REMOVAL AND THE PATIENT DECIDED TO HAVE THEM REMOVED (B)(6) 2019. ON (B)(6) 2019 THE REMAINING TWO BALLOONS WERE IDENTIFIED IN THE PATIENT'S STOMACH, INFLATED WITH APPEARANCE AS EXPECTED, AND WITH NO MIGRATION INTO THE LOWER IN

  Patient problems: Vomiting

  MAUDE report 8324038 ↗
• MalfunctionJan 18, 2019Leak/Splash; Leak/Splash

  A SINGLE DEFLATED BALLOON WAS IDENTIFIED AT A NORMALLY SCHEDULED ENDOSCOPIC REMOVAL IN A FEMALE PATIENT WITH A FIRST BALLOON PLACEMENT OF (B)(6) 2018, SECOND BALLOON PLACEMENT OF (B)(6) 2018, AND THIRD BALLOON PLACEMENT OF (B)(6) 2018. THE BALLOON WAS IDENTIFIED IN THE PATIENT'S STOMACH WITH NO MIGRATION INTO THE LOWER INTESTINE DURING THE NON-EMERGENT, SCHEDULED BALLOON REMOVAL ON (B)(6) 2018. ALL BALLOONS WERE SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION BUT WERE NOT RETURNED TO OBALON FOR INVESTIGATION. THE PATIENT WAS REPORTEDLY NOT ALWAYS COMPLAINT WITH PPI MEDICATIONS AND INSTEAD WAS TAKING NON-PPI ANTACIDS MOST OF THE TIME. THERE WAS NO INJURY ASSOCIATED WITH THE DEFLATED BALLOON.

  Patient problems: No Information

  MAUDE report 8262479 ↗
• InjuryDec 12, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  A FEMALE PATIENT WITH FIRST BALLOON ADMINISTRATION ON (B)(6) 2018, SECOND BALLOON ADMINISTRATION ON (B)(6) 2018, AND THIRD BALLOON ADMINISTRATION ON (B)(6) 2018, PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO REPORTED INCREASING LUQ ABDOMINAL PAIN OVER 72 HOURS. FREE PERITONEAL AIR OBSERVED IN THE UPPER ABDOMEN COMPATIBLE WITH GASTRIC PERFORATION WAS FOUND BY A CT SCAN. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL THAT THE PRESCRIBING BARIATRIC SURGEON HAD RIGHTS TO. THE PATIENT DID NOT REPORT TAKING PRESCRIBED PPIS PER THE HOSPITAL MEDICAL RECORDS. THE BALLOONS WERE REMOVED ENDOSCOPICALLY FROM THE STOMACH ON (B)(6) 2018 AND WERE DISCARDED. THE TREATING PHYSICIAN DESCRIBED A FULL-THICKNESS ULCER IN THE ANTEROLATERAL ASPECT OF THE STOMACH ALONG THE MID BODY. A PHOTOGRAPH OF THE ULCER SHOWED A DEEP CRATERED ULCER WITH FIBRINOUS DEBRIS AS THE HEALING PROCESS WAS IN EFFECT. THE STOMACH PERFORATION WAS SURGICALLY REPAIRED LAPAROSCOPICALLY BY GASTRIC RESECTION ON (B)(6) 2018. THE PHYSICIAN INDICATED THAT THE PERFORATION MAY HAVE BEEN DUE TO PRESSURE NECROSIS SECONDARY TO CHRONIC NSAID USE. HOWEVER, CLARIFIED THAT THE EVENT WAS MOST LIKELY DUE TO MECHANICAL ABRASION WHICH BROKE THE MUCOS

  Patient problems: Abdominal Pain; Perforation; Ulcer

  MAUDE report 8157918 ↗
• MalfunctionNov 14, 2018Leak/Splash; Leak/Splash

  A MALE PATIENT WITH A FIRST BALLOON PLACEMENT OF (B)(6) 2018, SECOND BALLOON PLACEMENT OF (B)(6) 2018, AND THIRD BALLOON PLACEMENT OF (B)(6) 2018 WAS FOUND TO HAVE ONE OF THREE BALLOONS DEFLATED IN THE STOMACH DURING THE SCHEDULED ROUTINE ENDOSCOPIC REMOVAL ON (B)(6) 2018. THE PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED A NEW ONSET OF SYMPTOMS OF ABDOMINAL PAIN. ALL BALLOONS WERE SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION AND THE DEFLATED BALLOON WAS RETURNED TO OBALON FOR INVESTIGATION. THERE WAS NO SERIOUS INJURY DUE TO THE DEFLATED BALLOON.

  Patient problems: Abdominal Pain

  MAUDE report 8071408 ↗
• MalfunctionOct 26, 2018Leak/Splash; Leak/Splash

  A FEMALE PATIENT WITH A FIRST BALLOON PLACEMENT OF (B)(6) 2018, SECOND BALLOON PLACEMENT OF (B)(6) 2018, AND THIRD BALLOON PLACEMENT OF (B)(6) 2018. REMOVAL WAS SCHEDULED FOR (B)(6) 2018. ON (B)(6), THE PATIENT EXPERIENCED A NEW ONSET OF SYMPTOMS OF NAUSEA AND VOMITING ON AND REPORTED THESE NEW SYMPTOMS TO THE PRESCRIBING PHYSICIAN. SINCE THE REMOVAL WAS SCHEDULED FOR THE FOLLOWING MORNING AND THE SYMPTOMS DID NOT APPEAR TO BE LIFE-THREATENING, BALLOON REMOVAL WAS NOT RESCHEDULED AND OCCURRED ON (B)(6) 2018. DURING RETRIEVAL, ONE BALLOON WAS IDENTIFIED AS DEFLATED IN THE DISTAL PART OF THE STOMACH, ONE BALLOON WAS PARTIALLY INFLATED IN THE STOMACH, AND ONE BALLOON WAS FULLY INFLATED IN THE STOMACH. ALL BALLOONS WERE SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION AND WERE RETURNED TO OBALON FOR INVESTIGATION. THERE WAS NO SERIOUS INJURY DUE TO THE DEFLATED BALLOON.

  Patient problems: Nausea; Vomiting

  MAUDE report 8010392 ↗
• MalfunctionSep 19, 2018Leak/Splash; Leak/Splash

  A FEMALE PATIENT WITH A FIRST BALLOON IMPLANTATION DATE OF (B)(6) 2018, SECOND BALLOON PLACEMENT OF (B)(6) 2018, AND THIRD BALLOON PLACEMENT OF (B)(6) 2018, EXPERIENCED A NEW ONSET OF SYMPTOMS OF NAUSEA ON (B)(6) 2018 AND REPORTED THESE NEW SYMPTOMS TO THE PRESCRIBING PHYSICIAN. THE BALLOON REMOVAL HAD BEEN SCHEDULED FOR (B)(6) 2018 BUT WAS CANCELLED SINCE THE PATIENT WAS OUT OF THE COUNTRY. BALLOON REMOVAL OCCURRED ON (B)(6) 2018 AND DURING ENDOSCOPY, ONE BALLOON WAS IDENTIFIED AS DEFLATED IN THE ANTRUM OF THE STOMACH AND ULCERS WERE OBSERVED. ALL BALLOONS WERE SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION AND WERE RETURNED TO OBALON FOR INVESTIGATION. THERE WAS NO SERIOUS INJURY DUE TO THE DEFLATED BALLOON. NO SURGICAL INTERVENTION WAS PERFORMED DUE TO THE ULCERS AND THE PATIENT WAS PRESCRIBED CARAFATE. THE PATIENT HAD PRE-EXISTING CONDITIONS OF LUPUS AND RHEUMATOID ARTHRITIS AND STATED THAT THEY WERE IN REMISSION DURING THE INITIAL BALLOON ADMINISTRATION, HOWEVER THE PATIENT WAS TREATED WITH CHEMOTHERAPY IN (B)(6) 2018.

  Patient problems: Abdominal Pain; Nausea; Ulcer

  MAUDE report 7890821 ↗
• MalfunctionJul 18, 2018Leak/Splash; Leak/Splash

  A FEMALE PATIENT WITH A FIRST BALLOON IMPLANTATION DATE OF (B)(6) 2017, SECOND BALLOON PLACEMENT OF (B)(6) 2018, AND THIRD BALLOON PLACEMENT OF (B)(6) 2018 HAD A SCHEDULED REMOVAL ON (B)(6) 2018 AT A GI FACILITY. THE REMOVING GI SUCCESSFULLY REMOVED TWO BALLOONS WHICH WERE DISCARDED. THE PRESCRIBING PHYSICIAN SUBSEQUENTLY NOTED THAT THE PATIENT HAD THREE BALLOONS IMPLANTED AND THAT ONLY TWO BALLOONS WERE REMOVED DURING PREPARATION OF THE POST-OP VISIT SCHEDULED FOR (B)(6) 2018. THE PATIENT CONFIRMED THAT THEY HAD EXPERIENCED A NEW ONSET OF SYMPTOMS OF NAUSEA AND STOMACH PAIN IN APPROXIMATELY (B)(6) 2018 AND SAW A FOREIGN OBJECT IN THEIR STOOL WHICH COULD HAVE BEEN THE BALLOON. THE BALLOON THAT WAS PASSED IN THE STOOL WAS NOT RETRIEVED. THE PATIENT HAD NOT PREVIOUSLY REPORTED PASSING THE BALLOON TO THE PRESCRIBING PHYSICIAN BUT HAD REPORTED SYMPTOMS OF NAUSEA OF VOMITING FOR SEVERAL WEEKS WHICH HAD RESOLVED IN (B)(6) 2018. X-RAY IMAGING PERFORMED ON (B)(6) 2018 CONFIRMED THAT THE BALLOON WAS NOT IN THE PATIENT. THE PATIENT WAS DOING WELL AFTER THE REMOVAL OF THE REMAINING IMPLANTED BALLOONS WITH NO ISSUES POST REMOVAL AND THE PATIENT LOST 27 POUNDS DURING THE TREATMENT. THERE WAS NO

  Patient problems: Abdominal Pain; Nausea; Vomiting

  MAUDE report 7700299 ↗
• MalfunctionJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BALLOON DID NOT TRANSIT TO THE STOMACH DURING A FIRST BALLOON ADMINISTRATION FOR A FEMALE PATIENT ON (B)(6) 2018. THE PHYSICIAN PULLED THE BALLOON AND CATHETER OUT OF THE PATIENT AND IDENTIFIED THAT THE TRANSIT ISSUE WAS DUE TO AN ESOPHAGEAL STRICTURE. THE PHYSICIAN DECIDED TO ENDOSCOPICALLY PLACE THE BALLOON INTO THE STOMACH. AFTER THE BALLOON WAS ENDOSCOPICALLY PLACED IN THE STOMACH, THE PHYSICIAN PERFORMED THE EZFILL DISPENSER AND INFLATION CAN PREPARATION. THE DISPENSER PRESSURE FELL BELOW THE LABELED PRESSURE RANGE DURING DISPENSER PREP BY APPROXIMATELY 1 KPA. TWO ADDITIONAL INFLATION CANS WERE USED DURING ATTEMPTS TO PREP THE DISPENSER WITH THE SAME OUTCOME. DURING THE THIRD CAN INSERTION THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON DESPITE THE LOW-PRESSURE VALUE AND THE SYSTEM PRESSURE WENT TO 0 KPA AND THE BALLOON MINIMALLY INFLATED. A FOURTH CAN WAS INSERTED WITH ALL VALVES OPEN AND INFLATION WAS VIEWED THROUGH THE ENDOSCOPE. THE LAST PRESSURE READING WAS 24 KPA BEFORE THE BALLOON WAS EJECTED FROM THE CATHETER WITHOUT BLEEDING THE PRESSURE DOWN TO THE LABELED BALLOON INFLATION PRESSURE RANGE OF 9.0 - 13.0 KPA. THE PHYSICIAN STATED THAT THEY WERE UNSURE IF THE PRESSURE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7622383 ↗
• MalfunctionMay 18, 2018Material Puncture/Hole; Short Fill; Material Puncture/Hole; Short Fill

  A FEMALE PATIENT WITH A FIRST BALLOON PLACEMENT OF (B)(6) 2018, A FAILED SECOND BALLOON PLACEMENT ON (B)(6) 2018, DUE TO THE PATIENT BITING THE CATHETER DURING ADMINISTRATION, RECEIVED ANOTHER SECOND BALLOON PLACEMENT PROCEDURE ON (B)(6) 2018. THE BALLOON CAPSULE WAS SWALLOWED AND INFLATED DURING THIS BALLOON PLACEMENT, HOWEVER, AFTER BALLOON INFLATION, THE BALLOON PRESSURE BEGAN DECREASING. THE LAST OBSERVED BALLOON PRESSURE ON THE EZFILL DISPENSER PRIOR TO CATHETER EJECTION WAS 8.8 KPA WHICH IS OUTSIDE OF THE LABELED BALLOON INFLATION PRESSURE RANGE. REPRESENTATIVES FROM OBALON RECOMMENDED THAT THE PHYSICIAN REMOVE THE BALLOON ENDOSCOPICALLY ACCORDING TO THE LABELING. THE CATHETER WAS RETURNED TO OBALON FOR INVESTIGATION. A PATIENT X-RAY WAS PERFORMED ON (B)(6) 2018 DURING THE THIRD BALLOON PLACEMENT THAT INDICATED ALL THREE BALLOONS WERE INFLATED. ON (B)(6) 2018, THE PHYSICIAN COMMUNICATED TO OBALON THAT THEY DECIDED TO LEAVE THE SECOND BALLOON IMPLANTED AND MONITOR THE PATIENT VIA X-RAY. THE PATIENT WAS SCHEDULED FOR A TWO-WEEK FOLLOW-UP, HOWEVER WAS UNABLE TO MAKE THE APPOINTMENT. DURING A ONE-MONTH FOLLOW-UP BY PHONE WITH THE PRESCRIBING PHYSICIAN, THE PATIENT WAS DOING WELL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7525984 ↗
• MalfunctionMay 9, 2018Material Rupture; Material Perforation; Material Rupture; Material Perforation

  A MALE PATIENT SWALLOWED THE BALLOON CAPSULE AND THE PRESCRIBING PHYSICIAN STATED THAT VERIFICATION THAT THE BALLOON WAS IN THE STOMACH WAS DIFFICULT TO CONFIRM. THE ROOM USED FOR VISUALIZATION WAS NOT THE PHYSICIAN'S TYPICAL FLUOROSCOPY ROOM AND THE EQUIPMENT SETTINGS SEEMED INCORRECT. THE PHYSICIAN THOUGHT SHE COULD SEE THE VALVE BUT WAS UNCERTAIN. SHE INITIATED THE PRE-PULSE STAGE OF INFLATION AND THE PRE-PULSE PRESSURE WAS HOVERING AT 22 KPA BUT THEN THE PRE-PULSE PRESSURE JUMPED DOWN TO 5 KPA. THE PHYSICIAN EVACUATED THE BALLOON PRESSURE WITH THE 60 CC SYRINGE AND APPLE SAUCE WAS USED TO FACILITATE ESOPHAGEAL TRANSIT. THE VISUALIZATION OF THE VALVE WAS STILL DIFFICULT BUT SHE DECIDED TO PROCEED WITH INFLATION BUT INSTRUCTED THE PATIENT TO IMMEDIATELY NOTIFY HER OF ANY DISCOMFORT. BALLOON INFLATION WAS INITIATED WITH THE PHYSICIAN HOLDING THE EZFILL DISPENSER GREEN VALVE AND ASKED THE PATIENT FOR ANY SIGNS OF DISCOMFORT. WHEN THE PATIENT FELT AND COMMUNICATED SYMPTOMS OF PRESSURE, THE GREEN VALVE WAS CLOSED TO STOP THE BALLOON INFLATION. THE BALLOON WAS REMOVED BY ENDOSCOPY AND CONFIRMED IN THE ESOPHAGUS AND SUPERFICIAL MUCOSAL DAMAGE WAS NOTED. PATIENT REMAINS STABLE WITH NO S

  Patient problems: Pain

  MAUDE report 7501369 ↗
• InjuryJan 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WITH TWO BALLOONS IMPLANTED: FIRST IMPLANTATION DATE OF (B)(6) 2017 AND SECOND IMPLANTATION DATE OF (B)(6) 2017 PRESENTED STOMACH PAIN ON (B)(6) 2017 AND VISITED AN EMERGENCY ROOM. BOTH BALLOONS HAD BEEN IN THE STOMACH FOR APPROXIMATELY 2 MONTHS WITHOUT REMARKABLE SYMPTOMS OR COMPLAINT BY THE PATIENT TO THE PRESCRIBING PHYSICIAN. THE PATIENT STATED THEY HAD BEEN COMPLIANT WITH TAKING THE PRESCRIBED PROTON PUMP INHIBITORS OVER THE BALLOON TREATMENT. THE PATIENT WAS ALSO TAKING FOUR (4) PRESCRIBED ANTI-DEPRESSANT MEDICATIONS. PATIENT PRESENTED TO THE LOCAL ER COMPLAINING OF A NEW ONSET OF SEVERE STOMACH PAIN. THE PATIENTS HAD REPORTED NO SYMPTOMS ASSOCIATED WITH BALLOONS UNTIL PRESENTING TO THE ER. X-RAY AND A CT SCAN WERE PERFORMED WHICH SHOWED FREE AIR IN THE ABDOMEN INDICATING A PERFORATION IN THE STOMACH. THE BALLOONS WERE OBSERVED AS FULLY INFLATED AND SUCCESSFULLY REMOVED VIA ENDOSCOPY. THE DUODENUM WAS NORMAL, THE ABDOMEN WAS MORE DISTENDED POST EGD, AND THERE WAS A LARGE 1.5 TO 2 CM ULCERATED CRATER IN THE UPPER STOMACH (ANTERIOR SIDE) ALONG THE LESSER CURVATURE. THIS WAS TREATED WITH LAPAROSCOPY WITH AN OVER SEW OF THE ULCER WITH GRAHAM PATCH AND DRAIN PLACE

  Patient problems: Abdominal Pain; Perforation; Ulcer

  MAUDE report 7179644 ↗