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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 1012449-20
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2021
Event Type  malfunction  
Manufacturer Narrative
The device was received. 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 an 85% stenosed, mildly tortuous, and mildly calcified lesion in the distal right coronary artery. The 3. 0x20mm nc trek rx balloon dilatation catheter (bdc) was prepared per the instructions for use. The bdc was inflated to 12 atmospheres; however, it deflated and would no longer inflate. The balloon catheter was removed from the patient anatomy and once outside it was tested on the back table and a leak in the distal shaft was noted. The procedure was successfully completed with a 3. 0x20mm nc trek bdc. 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 Key12097330
MDR Text Key259420957
Report Number2024168-2021-05625
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
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012449-20
Device Catalogue Number1012449-20
Device Lot Number10120G2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2021
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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