Amt worked with the original reporter to obtain the device for examination and performed an inspection of the device once it was returned.The device was thoroughly tested for leakage with no leakage or other defects.The balloon was also inflated and left to sit for 24 hours with no leakage found.A device history review was completed for the reported lot number and no anomalies were found and there have been no other complaints from the same batch.Recent trending data shows no anomalies in reported failures from the field.The complaint information has been logged into our complaint database for trending purposes.Complaint # (b)(4) was assigned to this report.Note that this record was originally identified as non-reportable as the returned device was found fully functional and not suspected to be the cause for the reported condition.However, a more recent review of the record determined that to air on the side of caution, a report should be sent to fda as the device cannot be definitively removed as a contributing cause to the patient's condition.However, it should be noted that the returned device was fully functional, so the reported occurrence is believed to be related to an undersized device, placement in a non-mature stoma, or improper inflation of the balloon.
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Per the original reporter, the balloon deflated after five (5) days of use and the patient presented with fevers and peritonitis, requiring an emergency laparotomy to repair the stomach and replace the gastric tube.The patient was then treated with 7 days of antibiotics and is now tolerating tube feeds.
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