It was reported that a patient was given versed and fentanyl and was placed under conscious sedation prior to undergoing a renal biopsy procedure.During the procedure, while the physician was taking sample of the lower pole transplant kidney, the biopsy needle veered into the medial portion of the guide path.This resulted in the biopsy needle hitting the collecting system.Reportedly, this was a deep and thick tissue which bent the needle out of the guide path.This resulted in a large bladder clot and the intervention provided by the physician was a placement of a foley catheter due to the clot.The procedure was completed with the same ultrasound system and the biopsy needle was not changed throughout the procedure.No additional information was provided.
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This supplemental report is being submitted to provide the date a new information was received and the type of report (see sections g4;g7)); provide the type of reportable event, provide the type of follow-up, and update the event problem and evaluation codes (see sections h1,h2,h6); and provide additional manufacturer narrative (see section h10).This supplemental report is being submitted because it was determined that the medical device report (mdr) initially submitted to the fda on 06/08/18 was filed in error.Based upon the siemens customer service engineer (cse) and the customer going through the needle guide operation, they found that the needle and the representation on the monitor were accurate.They found that if the needle encounters something that is firm, it would bend and the needle would display outside of the needle guide on the monitor.The system is working as designed, there was no problem found "npf".(b)(4).
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