It was reported the dragonfly opstar imaging catheter was used to evaluate a newly placed stent.Pullback was done successfully and according to the optical coherence tomography (oct) image, stent apposition and expansion were perfectly fine.When attempting to remove the dragonfly opstar catheter, a lot of pressure had to be used.Unfortunately, this led to a longitudinal compression of the implanted stent and approximately 10-20mm of the distal part of dragonfly catheter separated inside the patient.Another stent was used to jam the separated segment between this new stent and up against the artery wall.The patient is doing fine.After discussion with three physicians, it is suspected a stent strut got stuck in the opening of the monorail catheter opening.There was no clinically significant delay in the procedure.No additional information was provided.
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H6: medical device problem code 2017 added.The device was not returned for evaluation.A query of the corrective action tracking system for the web (catsweb) database for the reported lot revealed there is no indication of a lot specific issue.In this event, it was reported that excess pressure/force was applied against resistance when attempting to remove the catheter.The instruction for use (ifu) for opstar imaging catheter caution the user that ¿if resistance is encountered during withdrawal of the dragonfly opstar imaging catheter: - stop manipulation and evaluate under fluoroscopy¿.If the cause of the resistance cannot be determined or mitigated, carefully remove the dragonfly opstar imaging catheter and guide wire as a unit from the patient.¿.In this case, the user continued to pull against resistance which caused the subsequent damage and material separation.The reported difficulty to remove, material separation, and device damaged by another device was determined to be related to operational context.In this case, it is likely that the catheter or guidewire became caught on a portion of the stent¿which caused the reported difficulty to remove.The subsequent damage by another device and material separation were due to the excess force applied by the user to remove the catheter from the patient anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Based on the reported information and results of the complaint investigation there is no indication the reported difficulty to remove, material separation, and device damaged by another device are related to a potential product quality issue.
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