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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 02/01/2022
Event Type  Injury  
Manufacturer Narrative
There was no reported device malfunction and the product was not returned. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effect of dissection is listed in the coronary dilatation catheters (cdc), traveler rx, global, instruction for use as a known patient effect. A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined. Additionally, the treatment appears to be related to operational context of the procedure. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The traveler rx device 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 moderately calcified, heavily tortuous left anterior descending artery. After the use of a 2. 0x15mm traveler balloon dilatation catheter (bdc) a dissection occurred. It was noted the bdc was inflated once to 12 atmospheres. The dissection was covered with an unspecified stent and procedure was completed successfully. There was no adverse patient sequela and no clinically significant delay reported. 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 Key13653235
MDR Text Key286450431
Report Number2024168-2022-02129
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
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 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1013065-15
Device Lot Number00328G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2020
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: 03/02/2022 Patient Sequence Number: 1
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