(b)(4).Device evaluated by mfr: the device was returned for analysis.The device has wire broken by tension overload near to the distal section (the distal tip was returned)121cm from the proximal section.Also it has the distal tip stretched, kinked, unraveled, and the wire is kinked in the middle of the device.The overall length couldn't be measured due to the wire broken.The outer diameter of distal tip couldn't be measured due to the device condition (distal tip stretched, kinked, unraveled).The outer diameter of middle of the device near to the broken section and the outer diameter of proximal section are within specifications.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 (b)(6) 2016.It was reported that a rotawire kink occurred.The 90% stenosed target lesion was located in the severely calcified and moderately tortuous coronary artery.A 330cm rotawire® and a rota burr were selected for use.During the procedure, it was noted that the rotawire was kinked.The procedure was completed using another of the same device.No patient complications were reported and the patient's status was good.However, device analysis revealed a broken wire.
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