Age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr: the device was returned for analysis.The balloon is loosely folded with blood in the inflation lumen and balloon.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.There are numerous hypotube and shaft kinks.Microscopic examination of the device presented that a portion of the outer shaft was plastically deformed 9.8cm from the tip which also has a 2mm longitudinal tear.The balloon is intact and has no damage.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The inner shaft is buckled in numerous locations.The tip is damaged.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 reported difficulty, which could not be confirmed because the clinical circumstances could not be replicated.
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