(b)(4). device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.There was contrast on the outer surface of the device.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube shaft was completely separated 43.5cm 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 were numerous hypotube kinks.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).
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Reportable based on device analysis completed on 10-apr-2017.It was reported that shaft kink occurred.The 95% stenosed target lesion was located in the proximal right coronary artery (rca).A 3.5mm x 12mm quantum¿ maverick¿ balloon catheter was advanced 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 broken.
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