Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Device evaluated by mfr.: a visual examination of the crimped stent found the first proximal stent row was damaged with the strut lifted on one side and pulled distally.Visual examination of the crimped stent found the first proximal stent row was damaged with the strut lifted on one side and pulled distally.This type of damage is consistent with the stent encountering resistance in an attempt to withdraw the device.The undamaged crimped stent od(outer diameter) was measured using snap gauge and the result was 0.0480¿¿, this is within max crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon had not been subjected to any significant positive pressure.A visual and tactile examination of the device found no issue with the hypotube.An examination of the inner and outer shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.The tip was visually examined and no issues were noted.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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