(b)(4).Device evaluated by mfr.: returned product consisted of an emerge balloon catheter in two pieces.The balloon is loosely folded with blood in the inflation lumen and balloon.The outer shaft, inner shaft, balloon and tip were microscopically examined.The tip is damaged.The hypotube shaft was completely separated 59.7cm from the hub.The fracture faces were oval as if kinked prior to separation.There are numerous hypotube and shaft 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).
|