(b)(4).Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The balloon was loosely folded with blood in the balloon.The outer shaft, inner shaft, balloon and tip were microscopically examined.The tip is damaged.There are numerous hypotube and shaft kinks.The balloon has a pinhole at the markerband.Inspection of the remainder of the device presented no other damage or irregularities.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.Bsc id: (b)(4).Tw: (b)(4).
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