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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR UNK NC TREK RX CORONARY DILATATION CATHETER Back to Search Results
Catalog Number UNK NC TREK RX
Device Problems Deflation Problem (1149); Inflation Problem (1310); Failure to Advance (2524)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: 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.
 
Event Description
(b)(4). 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 nc trek rx dilatation catheter, the device issues include failure to cross, inflation and deflation issues. Details are listed in the attached article, titled post-market clinical follow-up evaluation report coronary dilatation catheters.
 
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Brand NameUNK NC TREK RX
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 Key12619325
MDR Text Key278105363
Report Number2024168-2021-09155
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K103153
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
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK NC TREK RX
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

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