Catalog Number UNK NC TREK RX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Angina (1710); Arrhythmia (1721); Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Ischemia (1942); Myocardial Infarction (1969); Vasoconstriction (2126); Perforation of Vessels (2135); Vascular Dissection (3160)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Date estimated the udi is unknown due to the part/lot number was not provided.The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional patient effects and malfunctions and devices reported in the article are captured under separate medwatch reports.Literature attachment.Article title: post-market clinical follow-up evaluation report coronary dilatation catheters.
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Event Description
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(b)(4): nc trek rx.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 january 2018 through june 2019.For the nc trek rx dilatation catheter, the adverse patient effects include perforation, dissection, myocardial infarction, arrhythmias, arteriorvenous fistula, coronary artery spasm, hemorrhage, hematoma, hypertension, hypotension, infection, and unstable angina.Details are listed in the attached article, titled post-market clinical follow-up evaluation report coronary dilatation catheters.
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Manufacturer Narrative
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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.The reported patient effects of perforation of vessels, vascular dissection, fistula, hypertension, infection, angina, myocardial infarction, hypotension, hematoma, hemorrhage, and arrhythmia are listed in the nc trek rx coronary dilatation catheter instructions for use (ifu) as known patient effects of coronary stenting procedures.Based on the information reported through the research article, a definitive cause of the reported perforation of vessels, vascular dissection, fistula, vasoconstriction, ischemia, hypertension, infection, angina, myocardial infarction, hypotension, hematoma, hemorrhage, and arrhythmia 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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Search Alerts/Recalls
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