The inflation catheter was returned to obalon for inspection, however the balloon was not returned.An engineering investigation was performed and the inflation catheter was visually inspected with optical microscopy and scanning electron microscopy (sem) and a breach (material rupture) was identified approximately 1 inch from the distal end.The breach could have potentially been caused by a patient bite to the catheter or catheter anomaly, however the root cause of breach is unknown.The balloon was removed endoscopically in accordance with the labeling and no serious injury was reported with this event.Per the labeling, do not rely solely on the gauge measurement for confirmation of placement in the stomach.You must confirm all pressure measurements with x-ray or fluoroscopy verification.During inflation, if there is indication of inflation in a constrained space (by pressure readings or patient symptoms), shut off the gas flow by closing the green valve, detach the catheter and evacuate the gas from the balloon with a 60 cc syringe.Proceed to the troubleshooting section.
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