Device is a combination product.(b)(4).Device evaluated by mfr: the complaint device was returned for analysis.No manifold returned.A visual and tactile examination of the device found that hypo tube was broken 1066 mm proximal to the midshaft bond with multiple kinks along the full catheter length.Kink 60 mm distal to mid shaft bond on mid shaft and a kink at the port skive.No issues inner or outer polymer extrusion.The crimped stent, balloon sections of the device were visually and microscopically examined and stent strut rows 6 to 10 and 13 from the proximal end of stent were pushed and deformed.Stent strut rows 7 to 10 from the distal end of the stent were pushed and deformed.No issues were noted with balloon.The tip was visually and microscopically examined and no issues were noted.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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Reportable based on device analysis completed on 08-dec-2016. it was reported that crossing difficulties were encountered. the 80% stenosed target lesion was located in the highly calcified right coronary artery (rca).A 6f jr 3.5 guide catheter was engaged, followed by a non-bsc guide wire was advanced, then pre-dilatation was done with a non-bsc balloon catheter.Subsequently, a 2.75x38mm promus element¿ plus stent was advanced but failed to cross the target lesion.Pre-dilatation was performed again at higher pressure and the procedure was completed with another with same device.No patient complications were reported and the patient's status was stable. however, returned device analysis revealed stent damaged and hypotube break.
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