• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR NC TRAVELER CORONARY DILATATION CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT VASCULAR NC TRAVELER CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1013154-15
Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2022
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a left anterior descending artery. A 3. 25x15 nc traveler balloon was being advanced when it met resistance with the calcified lesion but ultimately reached the lesion and performed inflations without any issues. During removal, resistance was noted with the guide catheter and the device became separated at the shaft (73 cm proximal from the distal tip) still within the guide catheter, therefore, the device was simply withdrawn. No separated portion remained in the anatomy. A xience stent was deployed to successfully complete the procedure. There was no adverse patient effects and no clinically significant delay. No additional information was provided.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNC TRAVELER 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 Key14808592
MDR Text Key295487224
Report Number2024168-2022-06836
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103153
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,Followup
Report Date 08/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1013154-15
Device Lot Number00211G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-