The physician indicated that the procedure occurred in (b)(6) 2017, with no exact date.The complainant was unable to report the upn and lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4).The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the mid-ureter during a cystoscopy, ureteroscopy and laser lithotripsy procedure on (b)(6) 2017.The exact day of the procedure was not provided.According to the complainant, during the procedure, a portion of the stone cone broke off during the procedure, and migrated proximally into the kidney.After the procedure, the physician felt a high index of suspicion, retrieved the stone cone device from the trash and examined the device.It was discovered to be missing a portion.The patient was returned to the operating room, and had the piece removed.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 stable.
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