• 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 TRAVELER RX 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 TRAVELER RX CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1013069-15
Device Problems Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  malfunction  
Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The traveler is currently not commercially available in the us; however, it is similar to a device sold in the us. Na.
 
Event Description
It was reported that the procedure was to treat a calcified lesion. A 3x15mm traveler balloon dilatation catheter (bdc) was advanced against resistance to the target lesion for dilatation. On the second inflation, at unknown atmospheres (atm), the balloon ruptured due to the calcified anatomy. The bdc was removed with resistance met from the anatomy and an unspecified stent was implanted. An nc balloon was used for post-dilatation to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12282263
MDR Text Key265211744
Report Number2024168-2021-06860
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,Followup
Report Date 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1013069-15
Device Lot Number00328G1
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 Received08/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

-
-