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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 1013066-15
Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2021
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 identified no other similar incidents and/or complaint from this lot. The investigation was unable to determine a conclusive cause for the reported inflation and deflation issues; however, the reported difficulty removing the device 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 this device. The traveler rx is currently not commercially available in the u. S. ; however, it is similar to a device sold in the u. S.
 
Event Description
It was reported that the procedure was performed to treat a 99% stenosed, moderately tortuous, and moderately calcified lesion in the mid left anterior descending artery. A 2. 25x15mm traveler rx balloon dilatation catheter (bdc) was prepared per the instructions for use and 50% contrast solution mix was used. The bdc was inflated twice at 8 atmospheres for 10 seconds during post-dilatation, but slow inflation was noted. During deflation, negative pressure was held for about 30 seconds; however, the balloon only partially deflated. The bdc was removed partially deflated and resistance with the anatomy was felt. The procedure was successfully completed therefore no replacement device was needed. There were no adverse patient effects and 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 Key12170686
MDR Text Key261718149
Report Number2024168-2021-06070
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 company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 07/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Catalogue Number1013066-15
Device Lot Number90131G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2019
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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