The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The returned stone cone was analyzed, and a visual inspection noted that the device was returned with the coil was exposed.The green coating of the coil was peeled near the distal end.The stone cone was unable to be closed fully.No other problems were noted.The reported event was confirmed.Based on all available information, it is most likely that the damage was caused due to procedural factors such as handling, technique, device manipulation or interaction with another device.Therefore, the most probable root cause is adverse event related to procedure.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.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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It was reported to boston scientific corporation that a stone cone was used in the kidney during an stone retrieval procedure performed on (b)(6) 2022.During the procedure, the stone cone did not open inside the patient.Another stone cone was used to complete the procedure.Investigation results revealed that the coil was peeled near the distal end; therefore, this is now an mdv reportable event.There were no patient complications reported as a result of this event.
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