The reported lot number 170318246 did not match with the upn provided (b)(4) therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Device problem code (b)(4) relates to the reported event of net detached.Manufacturing site name - (b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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Note: this report pertains to the third of five devices used during the same procedure.Refer to manufacturer report # 3005099803-2017-03734, 3005099803-2017-03735, 3005099803-2017-03737 and 3005099803-2017-03738 for the other associated device information.It was reported to boston scientific corporation that five rescuenet retrieval devices were used during an esophagogastroduodenoscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the net completely detached from the loop on five devices used consecutively.The detached components were retrieved successfully with forceps and the procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
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