It was reported that the procedure was to treat a de novo lesion in a heavily tortuous and mildly calcified proximal left anterior descending artery that was 90% stenosed.A 5.0 x 8 mm nc trek balloon catheter was used and the device was inflated twice at 12 and 16 atmospheres.However, it was not prepped (air aspiration) outside the anatomy prior to use.Additionally, the balloon failed to completely deflate.Therefore, all the devices were removed as a single unit and the balloon was removed partially deflated.Another same sized nc trek balloon catheter was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Internal file number: (b)(4).Evaluation summary: visual, dimensional and functional inspections were performed.The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device.A review of the lot history record identified one manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on review of the similar incidents, there is no indication of a lot specific issue.It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.The investigation determined the reported deflation issue appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
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