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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012455-12
Device Problems Break (1069); Material Separation (1562)
Patient Problem No Patient Involvement (2645)
Event Date 03/25/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that after unpacking the 5. 0x12mm nc trek balloon dilatation catheter (bdc), it was noted that the shaft was broken. There was no patient involvement and no clinically significant delay in the procedure. Another same sized device was used to successfully complete the procedure. No additional information was provided.
 
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Brand NameNC TREK CORONARY DILATATION CATHETER
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 Key9969358
MDR Text Key188098736
Report Number2024168-2020-03710
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,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Model Number1012455-12
Device Catalogue Number1012455-12
Device Lot Number90523G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2019
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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