Age at time of event: 18 years or older (b)(4).Returned product consisted of a coyote es balloon catheter.The shaft, hypotube, balloon and tip were microscopically examined.There was contrast and blood in the inflation lumen and balloon and blood in the balloon.The balloon was loosely folded.Microscopic examination of the balloon revealed two pinholes in the balloon wall at the proximal and distal edges of the markerband.There was material bunched up next to each pinhole.Microscopic examination presented no irregularities in the balloon material that could have contributed to the damage.The tip was damaged.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.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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