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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR TRAVELER RX CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1013065-15
Device Problems Difficult to Remove (1528); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2022
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue. The investigation determined the reported complaint appears to be related to operational context. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device. The traveler rx is currently not commercially available in the us; however, it is similar to a device sold in the us.
 
Event Description
It was reported that the procedure was to treat a lesion located in the 1st diagonal artery that was both moderately calcified and tortuous and 99% stenosed. The traveler rx 2. 00 x 15mm bdc failed to cross the lesion with an extension catheter due to the anatomy and there was resistance during removal with the lesion. There was no reported adverse patient effect and no clinically significant delay in the procedure. Additional treatment was not performed after the failure to cross. No additional information was provided.
 
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Brand NameTRAVELER RX 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 Key14569158
MDR Text Key293277733
Report Number2024168-2022-05858
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 06/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1013065-15
Device Lot Number00123G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2020
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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