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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 1013065-12
Device Problems Inflation Problem (1310); Leak/Splash (1354); Product Quality Problem (1506); Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 02/22/2021
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 device is not currently available commercially in the us; however, it is similar to a device sold in the us.
 
Event Description
It was reported that after preparation of the 2. 0x12mm traveler balloon dilatation catheter, the balloon was not in proper shape. It was then pressurized outside of the patient, but the balloon did not hold pressure and failed to inflate. A leak was observed from the balloon. The procedure was then aborted. 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 Key11449084
MDR Text Key240340939
Report Number2024168-2021-01886
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 company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1013065-12
Device Lot Number00328G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2021
Was Device Evaluated by Manufacturer? Yes
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

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