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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 1013069-12
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/19/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. 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 mildly tortuous, mildly calcified mid left anterior descending artery that was 75% stenosed. After a non-abbott guide wire successfully crossed, a 3x12mm traveler balloon was advanced and pre-dilated the lesion once at around 12 atmospheres for 20 seconds. The balloon was attempted to be deflated but it was difficult. Around 15 to 20 seconds were held negative to attempt to deflate the balloon. After a prolonged period of time, the balloon ultimately deflated. Then a 3. 5x24mm non-abbott stent was used to successfully complete the procedure. There was no adverse patient effects and no clinically significant delay. 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 Key10977910
MDR Text Key220505086
Report Number2024168-2020-10337
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1013069-12
Device Lot Number91125G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/25/2019
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: 12/09/2020 Patient Sequence Number: 1
Treatment
PROFIT 6F JL4; RUNTHROUGH NS
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