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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 1012449-25
Device Problems Difficult to Remove (1528); Material Separation (1562)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Foreign Body In Patient (2687)
Event Date 11/11/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number e2019001. The customer reported the device was discarded. 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 performed to treat a narrow lesion in the distal posterior tibial artery with moderate calcification. A 3. 0 x 25 mm nc trek balloon dilation catheter (bdc) was advanced to the target lesion, and balloon angioplasty was performed. However, there was resistance during removal of the bdc, and excessive force was applied. The distal end of the catheter became detached inside the patient, and became embedded with the stent. The patient remains hospitalized and the separated portion was not retrieved. There was 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 Key9465741
MDR Text Key175020565
Report Number2024168-2019-14494
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodePM
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 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue Number1012449-25
Device Lot Number80223G1
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 Received01/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/13/2019 Patient Sequence Number: 1
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