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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
Catalog Number 1012445-12
Device Problems Break (1069); Material Separation (1562); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. 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 the procedure was to treat a moderately calcified unspecified coronary artery. A 2. 0 x 12 mm nc trek balloon catheter was used; however, it became "damaged/broken" during procedure. There were no adverse patient effects. 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 Key9194704
MDR Text Key172926459
Report Number2024168-2019-12638
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 12/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue Number1012445-12
Device Lot Number70118G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2017
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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