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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 1012455-08
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem Insufficient Information (4580)
Event Date 03/31/2021
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot. The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device appears to be related to operational context. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a de novo lesion located in the proximal right coronary artery that was 90% stenosed. The nc trek balloon catheter was advanced to the lesion without issue. The balloon was inflated one time to 12 atmospheres (atm) for ten seconds but took more time than usual to deflate. During removal, resistance was met inside the stent, but the device was removed without further issue. There were no reported adverse patient effects and no clinically significant delay in the procedure. The procedure was completed with a non-abbott device. 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 Key11698333
MDR Text Key262965403
Report Number2024168-2021-03340
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 04/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012455-08
Device Catalogue Number1012455-08
Device Lot Number00828G1
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 Received04/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2020
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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