Age at time of event: 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual and tactile examination of the device found that there were multiple hypo tube kinks along the full catheter length.No issues with mid shaft, inner or outer polymer extrusion.The crimped stent, balloon sections of the device were visually and microscopically examined and strut 1 to 7 on the distal end of stent is undamaged.Strut 1 and 2 on the proximal end of the stent are lifted and deformed.Strut 3 and 4 look undamaged.The sent has been squashed together near the centre of the stent causing struts to overlap.No issues 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 considered handling damage as the event occurred without direct patient contact.(b)(4).
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