The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(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 a capio¿ slim was used during a vault suspension procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio cage failed to catch the needle.It was also reported that the capio carrier extended and retracted unsuccessfully.The needle then detached from the suture inside the patient and was not retrieved.The procedure was completed with another capio¿ slim.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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