It was reported to boston scientific corporation that an orbera intragastric balloon system was implanted into a patient on an unknown date.The balloon was discovered to be missing during the scheduled removal procedure, on an unknown date, indicating the balloon deflated and migrated from the patient.There were no patient complications reported as a result of this event.
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Block h6 imdrf code a1401 captures the reportable event of balloon deflated imdrf device code a010402 captures the reportable event of balloon migration imdrf device code f2202 captures the reportable event of gastroscopy procedure.Additional information: block a1, a2, a3, b3, b5, d4, d6a, e1, e2, e3 and h6.Investigation summary the device was not returned for product analysis.Instructions for use (ifu)/label review: a labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.The ifu contains detailed device information and instructions for the device use.Additionally, it was confirmed that the following adverse events are anticipated in the ifu: balloon deflated and balloon migration.Also, there is no evidence the device was improperly used per the ifu, and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Risk review: a risk review was completed and confirmed that the event of "endoscopic procedure, balloon deflated and balloon migration" were defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: for the as reported balloon deflated and balloon migration these adverse events are known and documented in the labeling and all reasonable steps have been taken (including both short or long term known complications or adverse reactions), for this reason these events are catalogued as "known inherent risk of device.".
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It was reported to boston scientific corporation that an orbera365 intragastric balloon system was implanted into a patient on (b)(6) 2022.The balloon was discovered to be missing with a gastroscope during the scheduled removal procedure, on (b)(6) 2023, indicating the balloon deflated and migrated from the patient.There were no patient complications reported as a result of this event.
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