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 cystocele, rectocele, enterocele, pubovaginal sling and vaginal suspension procedure on (b)(6) 2018.According to the complainant, during the procedure, the dart detached from the suture and was left in the ligament.X-ray was done but it showed no foreign body present in the patient.The capio device was used successfully several times after the issue.The patient's condition at the conclusion of the procedure was reported to be fine.
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