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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 No Consequences Or Impact To Patient (2199)
Event Date 10/26/2020
Event Type  malfunction  
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was performed to treat a 90% stenosed and mildly calcified de novo lesion in the proximal right coronary artery. A 4. 0x18mm xience sierra stent was deployed without issues. A 5. 0x8mm nc trek rx balloon dilatation catheter (bdc) was inflated once for post-dilatation; however, the balloon failed to deflate even after negative pressure was applied for at least 30 seconds. The bdc was eventually retrieved into the guide catheter with the balloon fully inflated and was removed with force. The procedure was successfully completed. There were no 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 Key10857304
MDR Text Key216936752
Report Number2024168-2020-09652
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,Followup
Report Date 11/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Model Number1012455-08
Device Catalogue Number1012455-08
Device Lot Number90426G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2019
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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