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 complaint device is not expected to 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 medwatch will be filed.
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It was reported to boston scientific corporation that a capio¿ slim was used during a sacrospinous fixation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart with 1cm suture detached and was retrieved from the patient.The procedure was completed with this device and a new suture.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 fine.
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