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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 1013064-15
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/18/2022
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis. 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 identified no similar incidents from this lot. The investigation was unable to determine a conclusive cause for the reported complaint. However, factors that may contribute to the difficult removing the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device. The traveler 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 90% stenosed, mildly calcified and mildly tortuous vessel in the proximal left anterior descending (lad) artery. After a stent was deployed in the lad, the 1. 5x15mm traveler rx balloon dilatation catheter (bdc) was applied to the side branch of the diagonal branch and inflated twice. First inflation was at 10 atmospheres (atms) and negative held at 5-10 seconds and after the second inflation at 14 atms and negative held also at 5-10 seconds, the balloon became stuck with the guide wire. There were no issues during preparation and there was no resistance with the guide wire during advancement. The balloon was fully deflated upon removal and it was confirmed that no attempts were made to move the guide wire while the balloon was pressurized/inflated. There were no issues with the guide wire. After removal of the bdc with the guide wire, another guide wire was re-inserted and another non-abbott balloon was used to complete the procedure. There was no adverse patient effect and there was no clinically significant delay in the procedure. 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 Key14621391
MDR Text Key293476290
Report Number2024168-2022-06039
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 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1013064-15
Device Lot Number00618G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2020
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: 06/07/2022 Patient Sequence Number: 1
Treatment
SION BLUE GUIDE WIRE 0.014
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