Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the returned product consisted of a coyote es balloon catheter.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.There is a pinhole 1mm from the proximal balloon waist and a pinhole 7mm from the markerband.There is tip damage.There was no evidence of any material or manufacturing deficiencies contributing to the damage.There are numerous hypotube and shaft kinks.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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