(b)(4).Title: post-market clinical follow-up evaluation report coronary dilatation catheters.It was reported that the post market clinical follow-up evaluation was performed to collect and evaluate clinical data in real-world clinical settings to confirm safety and performance on the use of the following dilatation catheters: trek rx, mini trek rx, traveler rx, nc trek rx and nc traveler rx.The procedures were performed between (b)(6) 2018 through (b)(6) 2019.For the nc trek rx dilatation catheter, the device issues include failure to cross, inflation and deflation issues.Details are listed in the attached article, titled post-market clinical follow-up evaluation report coronary dilatation catheters.
|
The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the lot and part numbers were not provided.Based on the information reported through the research article, a conclusive cause for the reported failure to advance, inflation problem and deflation problem could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|