Device evaluation summary: the angle trailblazer catheter was received for evaluation.The returned catheter was observed to be tangled and had a guidewire stuck inside the angle trailblazer catheter.Visual inspection of the angled trailblazer catheter shaft revealed multiple kinks to catheter shaft.All three marker bands were accounted for.The distal tip showed no abnormalities or deformities.The returned compatible 0.035in guidewire was observed to be damaged; the guidewire coating was torn and exposing the bare wire.There is evidence of twisting and kinking of the guidewire.The guidewire od was measure approximately 0.0335in.The guidewire was attempted to be retrieve from the catheter but was met with resistance and the guidewire was unable to be retrieved.There is evidence of accordion folding of the catheter underneath the strain relief.The customer experience of guidewire retrieval difficulty inside the angle trailblazer catheter was confirmed.The catheter shaft was sliced at the location, (approximately 22cm) where a 0.035in guidewire would not advance.The id was measured using a m-o model plus pin gage.The catheter lumen would accept pin gage sizes up to 0.035in.The cathet er lumen would not accept pin gage sizes 0.036in and higher.The catheter was sliced opened approximately 260cm to locate the distal end of the guidewire and verify if there were abnormalities.When the guidewire was removed from the catheter shaft, the distal tip appeared to be bent/kinked.Wet sanguine material was observed on the spring coil of the distal tip.If information is provided in the future, a supplemental report will be issued.
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Physician intended to use a trailblazer angled catheter with a 6fr sheath and non-medtronic 0.035¿ guidewire for the treatment of a severely calcified, moderately tortuous plaque lesion in the right superficial femoral artery of diameter 5mm.Anatomy abnormalities reported as long chronic total occlusion (cto).It was reported that ifu was followed during preparation.The vessel was pre-dilated.It was reported that during procedure, the non-medtronic wire got stuck inside of the 0.035 angled trailblazer and could not be removed.Physician ended up losing access and could not re-cross the cto.The physician then stopped procedure and treated proximal sfa.There was no patient injury reported.
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