The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that two spyscope access & delivery catheters and a spyglass digital controller were used during a spyglass procedure performed on (b)(6) 2020.According to the complainant, during the procedure, two new spyscope devices were opened and were not recognized by the spyglass digital controller.The procedure was not completed due to this event.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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