MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK NEO¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1400275-08
Medical Device Problem Codes	Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported inflation issue was confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.It was reported that the device was not soaked prior to use.It should be noted that the coronary dilatation catheters (cdc), nc trek neo, instruction for use states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unknown if the instructions for use (ifu) violation caused or contributed to the reported complaint.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported inflation issue and noted leak appear to be related to operational context.There was no leak or issue noted to the device during preparation, which suggests a product quality issue did not contribute to the reported difficulties.Return device analysis noted a tear located on the outer member on the side of the guidewire exit notch.In this case, it is likely that the device was inadvertently mishandled during preparation and/or during advancement such that the outer member became damaged (tore) and thus resulted in the reported inflation issue and noted leak.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code: 2017, failure to follow steps / instructions.
Event or Problem Description
It was reported the procedure was to treat a heavily calcified and tortuous lesion in the right coronary artery.The 2.75x8mm nc trek neo balloon dilatation catheter (bdc) was prepared for use outside the patient anatomy without issue; but was not soaked prior to use.The bdc was advanced with no resistance and inflated to nominal pressure; however, the balloon would inflate.The device was removed and another nc trek neo was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Return device analysis noted a tear in the outer member on the side of the guide wire exit notch.

• Brand Name: NC TREK NEO¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22781479
• Report Number: 2024168-2025-08342
• Device Sequence Number: 12826000
• Product Code: LOX
• UDI-Device Identifier: 08717648232459
• UDI-Public: (01)08717648232459(17)270531(10)40624G1
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K220634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1400275-08
• Device Catalogue Number: 1400275-08
• Device Lot Number: 40624G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown