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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 1012454-20
Device Problems Failure to Fold (1255); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
Event Type  malfunction  
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that this was a coronary intervention procedure in the right coronary artery. A non-abbott 4. 0x30 mm stent was implanted. The 4. 5x20 mm nc trek was inserted to post-dilate the stent. The nc trek was inflated five times; first in the distal stent for 14 seconds at 12 atmospheres (atms), then in the more proximal segment for 31 seconds at 18 atms, again more proximal for 18 seconds at 16 atms, then for 25 seconds at 18 atms. The final inflation was at the ostium right inside the stent for 21 seconds at 20 atms. The nc trek was reported to be fully deflated before it was pulled into the guide catheter for removal, but the nc trek became stuck in the guide catheter. The guide catheter and nc trek were removed together along with the sheath. Outside the body, the nc trek was found to be scrunched up from the attempts to remove it from the guide catheter. The nc trek was also difficult to remove from the sheath and the nc trek separated in two pieces. Vessel access was lost, so a new sheath and new guide catheter were inserted. The procedure was completed with good final result. There were no adverse patient effects and no clinically significant delay in the procedure. There was no additional information provided.
 
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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 Key12367869
MDR Text Key268218347
Report Number2024168-2021-07533
Device Sequence Number1
Product Code LOX
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012454-20
Device Catalogue Number1012454-20
Device Lot Number10204G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2021
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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