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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 1012451-12
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 the procedure was performed to treat a lesion in the heavily calcified and moderately tortuous left anterior descending (lad) artery. The target lesion was prepared using a non-abbott cutting balloon. The 3. 5 x 12 mm nc trek was prepared without issue, advanced, inflated and deflated at the target lesion; however, after removal of the device, a fiber was noted on the balloon. The site cannot confirm if the balloon came in contact with any procedure material that could have left the fiber on the balloon. 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 Key9282667
MDR Text Key165696200
Report Number2024168-2019-13262
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeMY
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 01/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
Device Model Number1012451-12
Device Catalogue Number1012451-12
Device Lot Number81204G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2018
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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