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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR NC TRAVELER CORONARY DILATATION CATHETER

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ABBOTT VASCULAR NC TRAVELER CORONARY DILATATION CATHETER Back to Search Results
Catalog Number UNK NC TRAVELER RX
Device Problems Deflation Problem (1149); Inflation Problem (1310); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2019
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 nc traveler rx may be related to unsuccessful delivery, inflation, or deflation, dissection, 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
Mean age based on c1 data. Majority gender based on c1 data. The report data included two different methods (c1 and c2), with two different data collection date ranges. The date of occurrence is unknown and estimated as 07/01/2019, the earliest date reported with the earliest collection method. The udi is unknown due to the part/lot number was not provided. The additional devices, adverse events, and malfunctions indicated in the pmcf report are captured under separate medwatch report numbers. The traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us. The device was not returned for analysis. A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided. Based on the information reported through the research article, a conclusive cause for the reported failure to advance, inflation problem and deflation problem could not be determined. There is no indication of a product quality issue with respect to manufacture, design, or labeling. Article title: post market clinical follow-up evaluation report coronary dilatation catheters.
 
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Brand NameNC TRAVELER 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 Key12733747
MDR Text Key281331381
Report Number2024168-2021-09820
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
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 NC TRAVELER RX
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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