Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2022.The complainant was unable to report the device suspected upn and lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient codes e0602 and e050303 capture the reportable event of pulmonary embolism and cardiac arrest.Imdrf impact code f02 captures the reportable event of patient's death.
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Note: this report pertains to one of four devices used in the same patient and procedure.It was reported to boston scientific corporation that an imager ii, nephromax balloon, percutaneous access needle and 8/10 dilator sheath set were used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2022.During the cystoscopy stent placement, the patient had a cardiac arrest due to pulmonary embolism and died.In the physician's assessment, the patient's death was due to pulmonary embolism and not related to the devices used.
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