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.
|
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 detached from the suture during deployment of the capio device.The detached piece remained in the capio head.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.
|