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 complainant indicated that the device 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 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 on (b)(6) 2018.According to the complainant, during deployment of the capio slim device, the dart detached from the suture and was left inside the patient.The procedure was completed with this 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 stable.
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