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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK RX & VOYAGER NC CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012452-12
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 08/27/2020
Event Type  malfunction  
Manufacturer Narrative
The device was reportedly discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. Na.
 
Event Description
It was reported that an nc trek box with the outer labeling of 3. 75x12mm contained an nc trek balloon with the inner labeling of a 3x15mm nc trek. The device was not used and there was no patient involvement. 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 & VOYAGER NC
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 Key10548933
MDR Text Key207535902
Report Number2024168-2020-07808
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
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 10/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model Number1012452-12
Device Catalogue Number1012452-12
Device Lot Number80511G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/11/2018
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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