(b)(4).Returned product consisted of a quantum maverick balloon catheter in two pieces.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The tip is damaged.The hypotube shaft was completely separated 78.2cm from the hub.The fracture faces were oval as if kinked prior to separation.There was no evidence of any material or manufacturing deficiencies contributing to the damage.There are numerous hypotube kinks.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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Reportable based on device analysis completed on 07-dec-2017.It was reported that shaft kink occurred.The stenosed target lesion was located in the coronary artery.A 3.5mm x 12mm quantum¿ maverick¿ balloon catheter was selected to dilate the lesion.However, it was noted that the shaft was kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed hypotube break.
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