• 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 1013151-15
Device Problems Material Rupture (1546); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
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 of the reported lot did not indicate a lot specific quality issue. The investigation determined the reported complaints appear to be related to operational context. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device. The nc traveler 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 moderately tortuous and heavily calcified in-stent restenosis in the distal right coronary artery. A 2. 5x15mm nc traveler rx balloon dilatation catheter (bdc) was advanced; however, resistance with the stent was felt. Once at the target lesion, the pressure could not be increased to greater than nominal (12 atmosphere). The contrast was observed leaking out of the balloon under cine and the pressure spontaneously decreased; therefore, it was judged as balloon rupture. The procedure was successfully completed with a non-abbott balloon catheter. 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 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 Key12268769
MDR Text Key264794275
Report Number2024168-2021-06763
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 company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1013151-15
Device Lot Number00213G1
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 Received07/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2020
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: 08/03/2021 Patient Sequence Number: 1
Treatment
GUIDE CATHETER: 6FR JR4; GUIDE WIRE: SION BLUE
-
-