• 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 TREK 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 TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012454-08
Device Problems Deflation Problem (1149); Peeled/Delaminated (1454); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/11/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the nc trek was inflated three times at 12 atmospheres for ten seconds and successfully post-dilated the stent in the proximal right coronary artery. During removal, the nc trek met resistance at the entrance of the guiding catheter and could not enter the guiding catheter, thus the whole system was removed as a unit. Outside the anatomy the trek was re-inflated, but could not be deflated. There were no inflation and deflation issues with the nc trek during use in the anatomy. After removal of the device, there were damages noted such as resin of the balloon drew near the tip and the shaft was partially kinked. The noted damage was suspected to be due to the resistance met when the nc trek was attempted to be withdrawn to the guiding catheter. There was no adverse patient effect 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 TREK 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 Key9928278
MDR Text Key186733858
Report Number2024168-2020-03391
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,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012454-08
Device Catalogue Number1012454-08
Device Lot Number90627G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-