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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR UNK RX TREK CORONARY DILATATION CATHETER

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ABBOTT VASCULAR UNK RX TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number UNK RX TREK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
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)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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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Brand NameUNK RX TREK
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key12619121
MDR Text Key276191022
Report Number2024168-2021-09150
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK RX TREK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1
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