BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBALON BALLOON SYSTEM

    MDR report key: 7021429 · Received November 10, 2017

    Report

    Report Number
    3009256831-2017-00278
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    October 10, 2017
    Report Date
    November 10, 2017
    Manufacturer
    OBALON THERAPEUTICS, INC.
    Product Code
    LTI
    PMA / PMN Number
    P160001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OBALON'S LABELING ADDRESSES THE REPORTED EVENT WITH WARNINGS FOR MONITORING PATIENTS FOR SYMPTOMS.

    Description of Event or Problem · 1

    A FEMALE PATIENT WITH THREE BALLOONS IMPLANTED: FIRST IMPLANTATION DATE OF (B)(6) 2017, SECOND IMPLANTATION DATE OF (B)(6) 2017, AND THIRD IMPLANTATION DATE OF (B)(6) 2017. ALL THREE BALLOONS HAD BEEN IN THE STOMACH FOR APPROXIMATELY 3 MONTHS WITHOUT REMARKABLE SYMPTOMS OR COMPLAINT BY THE PATIENT TO THE PRESCRIBING PHYSICIAN. ON (B)(6) 2017, THE PATIENT EXPERIENCED EPIGASTRIC BURNING PAIN AND VOMITING. THE PRESCRIBING PHYSICIAN INDICATED THAT THE PATIENT HAD (B)(6) DURING THE BALLOON THERAPY TREATMENT. THE PATIENT FELT LIKE THERE WAS SOMETHING STUCK IN HER THROAT BUT WAS STILL ABLE TO EAT. BOWEL MOVEMENTS WERE REGULAR AND THERE WERE NO URINARY SYMPTOMS. ONE WEEK PRIOR THE PATIENT HAD REFLUX SYMPTOMS/NAUSEA AND HAD BEEN COMPLIANT WITH TAKING THE PRESCRIBED PROTON PUMP INHIBITORS OVER THE BALLOON TREATMENT. APPROXIMATELY 6 HOURS AFTER INITIAL ONSET OF SYMPTOMS, THE PATIENT VISITED AN EMERGENCY ROOM WHERE A CT SCAN AND LABS INCLUDING EKG, COMPREHENSIVE METABOLIC PANEL, LIPASE, CBC, AND URINALYSIS WERE PERFORMED. SYMPTOMS INCLUDED DYSPNEA, GAGGING, DRY HEAVING, ABDOMINAL FIRMNESS, AND EMESIS IS YELLOW. THE CT SCAN SHOWED 3 INFLATED BALLOONS IN A FLUID-FILLED DISTENDED STOMACH. THE PHYSICIAN NOTED THAT THERE WAS DECOMPRESSION AT THE LEVEL OF THE PYLORUS AND PROXIMAL DUODENUM WHICH MAY BE SECONDARY TO COMPRESSION FROM THE DISTENDED STOMACH ALL BALLOONS WERE VERIFIED AS INFLATED VIA CT SCAN. ALL LAB RESULTS WERE NORMAL. LIVER AND KIDNEY FUNCTIONS WERE NORMAL BASED ON THE LAB RESULTS. ADDITIONALLY, BASED ON THE WHITE BLOOD CELL, CREATINE, AND LIPASE RESULTS, PANCREATITIS WAS RULED OUT. THERE WAS FLUID IN THE STOMACH AND FECAL IN BOWLS (NO BOWEL OBSTRUCTION). THE PATIENT WAS GIVEN FLUIDS VIA IV, ZOFRAN, AND PROTONIX AND DILAUDID WITH ONLY MINIMAL IMPROVEMENT IN SYMPTOMS. THE PHYSICIAN FELT IT WOULD BE BEST TO REMOVE THE BALLOONS VIA ENDOSCOPY THAT NIGHT WITH THE INTENT OF RELEASING THE PATIENT AFTER REMOVAL. DURING ENDOSCOPY, A LARGE AMOUNT OF RETAINED FOOD WAS OBSERVED AND THE THREE BALLOONS WERE FOUND FULLY INFLATED WHICH WERE SUCCESSFULLY REMOVED FROM THE PATIENT'S STOMACH WITHOUT ISSUE. THE ATTENDING PHYSICIAN INDICATED THAT THE ENDOSCOPY PICTURES DEMONSTRATE THAT THERE WAS FOOD BENEATH THE THIRD BALLOON. THE HOSPITAL RECORDS ALSO INDICATE THAT THERE WAS FOOD PASSING THROUGH THE PYLORUS AND EXITING THE STOMACH. IT WAS ALSO CONFIRMED THAT THE BALLOON WAS NOT "LODGED" IN THE PYLORUS SINCE THERE WAS FOOD BENEATH IT. THERE WAS FOOD IN THE STOMACH AND DUODENUM AND THE VIEW OF THE DUODENUM WAS OBSCURED DUE TO THE AMOUNT OF FOOD. THE BALLOONS WERE DISCARDED BY THE HOSPITAL AND THEREFORE NOT RETURNED TO OBALON FOR INVESTIGATION. THE PATIENT CONTINUED TO HAVE PAIN AFTER BALLOON REMOVAL, FOR THIS REASON, THE ATTENDING GI DECIDED TO ADMIT THE PATIENT FOR AN OVERNIGHT STAY FOR OBSERVATION WHILE ADMINISTERING NARCOTICS AND IV FLUID. THE PATIENT WAS DISCHARGED IN THE MORNING WITH A LAXATIVE AND HAS NOT CALLED WITH ANY ADDITIONAL PAIN SINCE. OBALON AND A MEDICAL REVIEWER INVESTIGATED THE EVENT INFORMATION. THE MEDICAL REVIEWER INDICATED THAT DUE TO THE AMOUNT OF FOOD CONTAINED IN THE STOMACH A POSSIBLE GASTRIC OUTLET OBSTRUCTION IS REMOTE GIVEN THAT FOOD WAS PRESENT DISTAL TO THE DISTAL BALLOON. THE MEDICAL REVIEWER FELT THAT A POTENTIAL CAUSE OF THE EVENT COULD ALSO BE A SUDDEN CHANGE IN GASTRIC MOTILITY BUT THAT IS MORE REPRESENTATIVE TO THE STOMACH AND SMALL BOWEL, AND NOT FROM GASTRIC OUTLET OBSTRUCTION. THE MEDICAL REVIEWER ALSO NOTED THAT THE PATIENT HAD ILEUS AFTER REMOVAL OF THE BALLOONS WHICH IS A POTENTIAL SIGN OF AN ACUTE GASTROENTERITIS. THIS COULD BE THE CAUSE OF THE SUDDEN ONSET OF VOMITING AND SYMPTOMS THAT ARE SIMILAR TO SYMPTOMS OF GASTRIC OUTLET OBSTRUCTION. IN SUMMARY, THE MEDICAL REVIEWER FELT THE CAUSE OF THE SYMPTOMOLY WAS MOST LIKELY NOT RELATED TO A GASTRIC OUTLET OBSTRUCTION SINCE THERE WAS FOOD IN THE STOMACH DISTAL TO THE DISTAL BALLOON AND IN THE DUODENUM AS WELL AS THE ILEUS OF THE SMALL BOWEL AFTER REMOVAL OF THE BALLOONS. THERE WAS ALSO NO RADIOGRAPHIC OR ENDOSCOPIC IMAGES OR REPORT THAT DEMONSTRATE THAT A BALLOON WAS WEDGED IN THE ANTRUM. PER THE LABELING, EACH PATIENT SHOULD BE MONITORED CLOSELY DURING THE ENTIRE DEVICE THERAPY PERIOD IN ORDER TO DETECT THE DEVELOPMENT OF POSSIBLE COMPLICATIONS. PATIENTS SHOULD BE INSTRUCTED REGARDING SYMPTOMS OF DEFLATION, GASTROINTESTINAL OBSTRUCTION, ULCERATION, ESOPHAGEAL INJURY, AND OTHER POSSIBLE COMPLICATIONS THAT COULD OCCUR, AND SHOULD BE ADVISED TO CONTACT THEIR PHYSICIAN IF THESE SYMPTOMS WORSEN OVER TIME OR PERSIST FOR MORE THAN 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800527 OBALON BALLOON SYSTEM INTRAGASTIC BALLOON LTI OBALON THERAPEUTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization