(b)(4).Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The balloon was tightly folded.There was contrast in the inflation.The hypotube shaft was completely separated 55cm from the hub.The fracture faces were oval as if kinked prior to separation.There were numerous hypotube kinks.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
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