Age at time of event: 18 years or older.
(b)(4).
Device evaluated by mfr: returned product consisted of a coyote es balloon catheter.
The balloon was loosely folded with blood in the lumen and balloon.
The outer shaft, inner shaft, balloon and tip were microscopically examined.
The tip is damaged.
There is a 21mm longitudinal balloon tear 18mm from the proximal markerband.
Inspection of the remainder of the device presented no other damage or irregularities.
There was no evidence of any damage or irregularities contributing to the damage and reported crossing difficulty.
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.
(b)(4).
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