(b)(4).Device evaluated by mfr: returned product consisted of a coyote es balloon catheter.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic examination of the balloon revealed no damage.Functional testing was performed by attaching an inflation device filled with water to the device.When positive pressure was applied, a stream of water emitted from the balloon wall.The balloon was microscopically examined and a pinhole in the balloon wall at the distal end of the markerband was revealed.There was a scratch to the left of the pinhole.Microscopic examination presented no irregularities in the balloon material that could have contributed to the damage.Microscopic examination revealed that 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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