(b)(4).Investigation results: a visual examination of the returned capio¿ slim revealed that the device does not have any failure.Functional analysis revealed that the carrier was actuated three times and it extended and retracted without any issues.Also, it was actuated (deployed) three times with the suture and the needle entered in the slot without any issues.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Based on all gathered information and investigation results, there is no evidence of either the alleged issue or any defect which could have contributed to the event.Therefore, the reported issue was unable to be confirmed.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
|
It was reported to boston scientific corporation that a capio¿ slim was used during a sacrospinous ligament fixation for apical prolapse procedure performed on (b)(6) 2017.According to the complainant, after deployment of the capio device at the right sacrospinous ligament approximately 2.5 cm medial to the ischial spine of the patient, the needle detached from the suture and was left inside the patient.The procedure was completed with this 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.
|