(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were microscopically examined.The proximal marker and distal marker were present.There was no damage.Visual and microscopic inspection of the device was unable to identify any damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
|