Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.There was blood in the inflation lumen and balloon.The balloon was loosely folded.The shaft was stretched and torn approximately 1cm distally from the exit notch.Microscopic examination presented no damage or irregularities to the balloon.Microscopic examination revealed that the distal 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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