(b)(4).Device evaluated by mfr.: returned product consisted of an apex balloon catheter.The balloon was loosely folded.The shaft, hypotube, and bonds were microscopically and visually examined.The shaft was completely separated 119.4cm from the hub.The fractured/separated ends of the shaft were stretched and jagged which indicates the shaft separation was due to tensile forces.There is tip damage.There was no evidence of any material or manufacturing deficiencies contributing to the damage.There were 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).
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