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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 1012455-15
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record identified one manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified two other similar incidents from this lot. The reported difficulty to remove from the guiding catheter appears to be related to operational context of the procedure due to the reported deflation problem. The investigation determined the reported deflation problem is related to a manufacturing issue. The issue is being addressed per internal operating procedures. Abbott vascular will continue to trend the performance of these devices. On january 15 2020, the abbott vascular determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter and nc traveler coronary dilatation catheter. The field safety action number is 2024168-1/29/2020-001-r. This action is being taken as a result of an increase in the complaint trend for reported failures of deflation for nc trek rx and nc traveler rx coronary dilatation catheter. Product from identified lots may exhibit slow, partial or failure to deflate.
 
Event Description
It was reported that the procedure was to treat a lesion located in the right coronary artery. A xience stent was implanted and then post dilated with a 5. 0x15 nc trek balloon dilatation catheter; however, the balloon would not deflate. Several attempts were made to inflate then deflate the balloon, but the balloon would not deflate. Subsequently, the entire system, including the guiding catheter, sheath and the 6fr system were removed as a unit. There was no reported adverse patient effects and no clinically significant delay in 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 Key10292940
MDR Text Key199534164
Report Number2024168-2020-05970
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
Remedial Action Notification
Type of Report Initial
Report Date 07/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2020
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2022
Device Model Number1012455-15
Device Catalogue Number1012455-15
Device Lot Number90806G1
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 Received07/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1133- 2020

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