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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012455-12
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2022
Event Type  malfunction  
Event Description
It was reported that the 5. 0x12mm nc trek balloon dilatation catheter (bdc) was prepared for use without issue and according to the instructions for use (ifu). The procedure was to treat a de novo lesion located in the left main that was moderately calcified. An unspecified stent was implanted and post-dilated. Intravascular ultrasound (ivus) showed the stent was well apposed to the vessel wall, but needed some post-dilatation. The nc trek was advanced to the stent without reported issue and successfully post-dilated the stent. During removal of the bdc, the distal tip of the balloon was stuck with the deployed stent but was able to be pulled back to the guide catheter, but unable to be pulled into the guide catheter. The entire system had to be removed as a unit. Although there was no reported inflation or deflation issue, when outside the patient, it was noticed that the shaft was kinked and the balloon was not fully deflated, as the distal tip of the balloon was not fully deflated. There was no reported adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
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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 Key13499017
MDR Text Key288785866
Report Number2024168-2022-01342
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648152146
UDI-Public08717648152146
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012455-12
Device Catalogue Number1012455-12
Device Lot Number10324G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2021
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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