The post-market clinical follow-up (pmcf) report, titled ¿post market clinical follow-up evaluation report coronary dilatation catheters¿ evaluated the safety and performance of the trek rx, mini trek rx, traveler rx, nc trek rx, nc traveler rx, nc trek otw, trek otw, mini trek otw, and mini trek ii otw.It was reported through a pmcf report that the nc traveler rx may be related to unsuccessful delivery, inflation, or deflation, dissection, myocardial infarction, and arrhythmias.Although the above events were noted, in conclusion, the overall analyses from this study demonstrates that the use of the abbott dilatation catheters met the safety and performance criteria.That they perform similarly to similar competitive devices.
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Mean age based on c1 data.Majority gender based on c1 data.The report data included two different methods (c1 and c2), with two different data collection date ranges.The date of occurrence is unknown and estimated as 07/01/2019, the earliest date reported with the earliest collection method.The udi is unknown due to the part/lot number was not provided.The additional devices, adverse events, and malfunctions indicated in the pmcf report are captured under separate medwatch report numbers.The traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number 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.Article title: post market clinical follow-up evaluation report coronary dilatation catheters.
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