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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 1012447-15
Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/09/2022
Event Type  Injury  
Event Description
It was reported that the procedure to treat a heavily calcified left anterior descending artery. The 2. 5x18mm nc trek balloon dilatation catheter (bdc) was inserted and advanced to the target lesion without difficulty. After inflating and fully deflating the balloon, the bdc was attempted to be removed; however, the bdc met resistance with anatomy. Additional force was applied to the device and once removed it was observed that a portion of the balloon had detached. The separated portion was removed via snare. Two unspecified stents were implanted to successfully complete the procedure. There was no adverse patient sequela and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
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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 Key14565145
MDR Text Key293079346
Report Number2024168-2022-05829
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151767
UDI-Public08717648151767
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012447-15
Device Catalogue Number1012447-15
Device Lot Number10823G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2021
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: 06/01/2022 Patient Sequence Number: 1
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