Sterling balloon catheter was received for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 8mm from the tip.Functional testing was performed by inflating the device and the only leak found was coming from the pinhole.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the leak at the hub.
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Reportable based on device analysis completed on 15mar2024.It was reported that balloon hub leak occurred.The patient was presented for carotid artery stenting.A 3.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during inflation, it was confirmed that the balloon hub was leaking, and the balloon was unable to expand.The procedure was completed with another of same device.There were no complications reported and the patient condition was good.However, returned device analysis revealed a pinhole 8mm from the tip.
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