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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK II OTW CORONARY DILATATION CATHETER

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ABBOTT VASCULAR MINI TREK II OTW CORONARY DILATATION CATHETER Back to Search Results
Catalog Number UNK OTW MINI TREK II
Device Problems Deflation Problem (1149); Inflation Problem (1310); Failure to Advance (2524)
Patient Problem Insufficient Information (4580)
Event Date 12/17/2020
Event Type  malfunction  
Event Description
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 ii 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.
 
Manufacturer Narrative
The otw device data was collected using only method c2. The grouped data was collected from 12/17/2020 to 01/18/2021. 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 attached 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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Brand NameMINI TREK II OTW CORONARY DILATATION CATHETER
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 Key12733959
MDR Text Key281743671
Report Number2024168-2021-09835
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 11/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK OTW MINI TREK II
Was Device Available for Evaluation? No
Date Manufacturer Received10/11/2021
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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