Product analysis: the nanocross pta dilatation catheter was received within a sealed large white envelope, within a sealed tyvek pouch, within a sealed plastic biohazard pouch, within its opened labeled shelf carton, and loosely coiled within its opened label pouch.No ancillary devices nor procedural images were received for analysis.The nanocross catheter was received with the balloon chamber in a post-inflated profile, (e.G.Not tightly wrapped and winged), the balloon chamber was separated at the proximal cone, and the balloon chamber inner guidewire was stretched/necked down.The balloon chamber was separated from the inflation lumen approximately 127.5cm from the y-manifold distal tip.The proximal end of the balloon chamber is approximately 165.4 mm.All the marker bands are accounted for.The proximal fracture face exhibits necking down at the proximal balloon bond and torsional radial separation.The distal fracture face exhibits radial separation.If information is provided in the future, a supplemental report will be issued.
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