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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 1012454-12
Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Event Date 04/02/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device will not be returned for evaluation, the device was reportedly 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 to treat a moderately tortuous, 99% stenosed lesion in the right coronary artery (rca). A 4. 5x12mm nc trek balloon dilatation catheter (bdc) was advanced to the lesion and inflated 3 times from 12 to 16 atmospheres (atm) and held for 10 seconds but could not be pulled back into the catheter to be removed from the anatomy. The patient¿s blood pressure (bp) and heart rate dropped, and all the devices were pulled out of the anatomy as a single unit with force. The patient was given medications to successfully treat the hypotension and bradycardia. There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy. 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 Key14463210
MDR Text Key292501423
Report Number2024168-2022-05475
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648152108
UDI-Public08717648152108
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012454-12
Device Catalogue Number1012454-12
Device Lot Number10921G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2021
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: 05/20/2022 Patient Sequence Number: 1
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