Based on the reported information, it was determined that an adverse event should be reported to fda as a duodenum perforation was found in the small intestines of the patient three days after a micro g-jet placement.However, it is unclear as to what caused the perforation to occur.The information provided to the amt sales representative indicated that the patient only weighed 3kg.The instructions of use for the device calls out that the device is only indicated for patients over 6kg.Therefore, the device was placed in a patient outside of the indicated size range.Amt requested the device for examination, but it was determined that the device had been discarded and would not be returned.It is not believed that the perforation is related to the micro gj device.The tube placement follows the guidewire that is placed previously to the tube placement, which is most likely the cause for the perforation occurrence.Amt complaint #: (b)(4) was logged to document this complaint.
|