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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 1012433-20
Device Problems Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
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. The balance middleweight universal guide wire device referenced is being filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was performed to treat a heavily calcified, mildly tortuous left coronary artery. A 2. 0x20mm otw nc trek balloon dilatation catheter was advanced over a balance middleweight universal guide wire with resistance noted. The devices got twisted and subsequently got stuck with each other. During removal, the guide wire tip separated. The distal portion of the separated guide wire was simply removed with the nc trek as a single unit. A new unspecified balloon catheter and guide wire were used to continue the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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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 Key9516933
MDR Text Key178172606
Report Number2024168-2019-14970
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151064
UDI-Public08717648151064
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Model Number1012433-20
Device Catalogue Number1012445-20
Device Lot Number90620G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2019
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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