(b)(4).Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The balloon was tightly folded.The hypotube, inner shaft, and outer shaft were microscopically and tactile inspected.Inspection revealed numerous kinks in the hypotube at 41.5cm and 65cm from the strain relief with a shaft fracture 61.5cm (from the strain relief).The fracture faces were oval in shape, as if kinked prior to separation.Inspection of the remainder of the device found no other damage or irregularities.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).
|