The exact age of the patient is unknown.However, it was reported the patient was over 18 years.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 device was used during a sacrospinous ligament suspension procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart detached from the suture after deployment of the device.Reportedly, the physician could no find the dart.The procedure was completed with another capio¿ slim device.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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