Catalog Number UNK RX TREK |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Angina (1710); Arrhythmia (1721); 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); Stenosis (2263); Obstruction/Occlusion (2422); Vascular Dissection (3160); Embolism/Embolus (4438)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: estimated date.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 death and malfunctions and devices reported in the article are captured under separate medwatch reports.Article title: post-market clinical follow-up evaluation report coronary dilatation catheters.
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Event Description
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Cn-(b)(4): 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 (b)(6) 2018 through (b)(6) 2019.For the trek rx dilatation catheter, the adverse patient effects include perforation, dissection, myocardial infarction, arrhythmias, coronary artery spasm, embolism, hemorrhage, hematoma, hypertension, hypotension, infection, restenosis, occlusion, ischemia and unstable angina.Details are listed in the 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 stenosis, perforation, dissection, myocardial infarction, embolism, hypertension, infection, obstruction/occlusion, angina, arrhythmia, hemorrhage, hematoma, and hypotension are listed in the trek rx coronary dilatation catheter instructions for use (ifu) as known patient effects.A definitive cause of the reported patient effects of stenosis, perforation, vascular dissection, myocardial infarction, vasoconstriction, embolism, hypertension, infection, obstruction 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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