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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012449-20
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that this was a percutaneous coronary intervention treating the proximal left circumflex (cx) lesion. An unspecified stent was implanted in the proximal cx. Post-dilatation was performed using an nc trek for two inflations (10 atms for 11 seconds, 10 atms for 20 seconds) without issues. After the third inflation (15 atms for 12 seconds), the balloon was unable to deflate. Negative was pulled greater than 30 seconds and the balloon partially deflated. The nc trek was retracted into the guide catheter and all (guide catheter, nc trek, guidewire) was removed as a single unit. Once outside the anatomy, the nc trek was unable to be removed from the guide catheter. There was no damage noted to the implanted stent and no damage to the vessel. There was no adverse patient effect and there was no clinically significant delay. No additional information was provided regarding this issue.
 
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Brand NameNC TREK RX
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 Key9500970
MDR Text Key178334398
Report Number2024168-2019-14816
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 03/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012449-20
Device Catalogue Number1012449-20
Device Lot Number90724G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2019
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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