Date of event: the otw device data was collected using only method c2.The grouped data was collected from (b)(6) 2020 to (b)(6) 2021.The date of occurrence is unknown and estimated as (b)(6) /2020.The udi is unknown due to the part/lot number was not provided.Account unk united states as this report represents the survey data collected from the united states.This is a summary report.The device is not returning for analysis.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional devices, adverse events, and malfunctions indicated in the pmcf report are captured under separate medwatch report numbers.Article title: post market clinical follow-up evaluation report coronary dilatation catheters.
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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 otw mini trek device may be related to unsuccessful delivery, inflation, or deflation, dissection, perforation, 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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B3: the otw device data was collected using only method c2.The grouped data was collected from (b)(6) 2020 to (b)(6) 2021.The date of occurrence is unknown and estimated as (b)(6) 2020.D4: the udi# is unknown because the part and lot numbers were not provided.D4 and h4: the device expiration and manufacturing dates could not be provided as the device lot number was not provided and the device was not returned.E: account unk united states as this report represents the survey data collected from the united states.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.The patient effects listed are consistent with the product risk profile and are therefore expected.A definitive cause of the reported dissection, perforation, arrhythmia, myocardial infarction and the relationship to the product, if any cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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