Age at time of event: 18 years or older.(b)(4).Returned product consisted of a coyote nc balloon catheter.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube shaft was completely separated 33.2cm 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 were numerous hypotube and shaft kinks.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 analysis completed on (b)(6) 2017.It was reported that shaft kinked occurred.Vascular access was obtained utilizing cross over approach.The target lesion was located in the moderately tortuous and severely calcified below the knee vessel.A 3.0mmx30mmx143cm fg coyote nc (nc quantum apex) balloon catheter was advanced for dilatation.However, during delivery of the device, the shaft was pushed forcibly and the shaft got kinked.The procedure was completed with another of the same device replacing the approach into ipsilateral.No patient complications were reported and the patient's status was good.However, returned device analysis revealed hypotube break.
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