(b)(4).Examination of the returned complaint device revealed that the outer infusion sheath on the catheter shaft had burst and was leaking fluid.The inner sheath on the catheter shaft has been stretched and compressed onto the spiral cut aspiration lumen causing the sheath to interfere with the drive coil rotation.Functional analysis was done by completing the set up procedure and was noticed that the priming sequence was not functioning properly due to the outer infusion sheath being ruptured.They removed the outer plastic shell on the pod and disconnected the drive coil shaft from the motor.After disconnecting, the forward and reverse buttons on the mouse control were pushed and the motor did run in both directions forward and reverse.Dissection of the catheter shaft showed that the inside of the exhaust lumen was completely occluded with a heavy clot burden.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 analysis completed on 29jul2015.It was reported that during preparation, the device failed to prime.This 1.85mm jetstream atherectomy catheter was selected; however, the device would not prime and there was no motion from the distal tip of the catheter.The device was not used.The procedure was completed with a different device.No patient complications were reported and the patient's status is fine.However, device analysis revealed that the outer sheath burst.
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