MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK NEO¿ Coronary Dilatation Catheter; Catheters, Transluminal Coronary Angioplasty, Percutaneous

Model Number	1400200-12
Medical Device Problem Codes	Material Separation (1562); Deformation Due to Compressive Stress (2889); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that when removing the 2.0x12mm nc trek neo balloon dilatation catheter (bdc) from the packaging, the coil dispenser was noted to be kinked.When the bdc was removed from the coil dispenser, the proximal shaft was kinked and then separated at the kinked location.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that when removing the 2.0x12mm nc trek neo balloon dilatation catheter (bdc) from the packaging, the coil dispenser was noted to be kinked.When the bdc was removed from the coil dispenser, the proximal shaft was kinked and then separated at the kinked location.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported complaints were confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported kink and kink in the coil could not be determined; however, the reported separation appears to be related to operational context.Potential factors that may contribute to kink damage to the balloon dilatation catheter (bdc) and dispenser coil include, but are not limited to, mishandling during manufacturing, during receiving/storage at the account, and/or handling during removal from packaging for preparation.A conclusive cause for the reported complaints could not be determined.Additionally, it is likely that the hypotube separated at the reported kink upon manipulation of the device during removal from the hoop/coil.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK NEO¿ Coronary Dilatation Catheter
• 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--462 ; +1(951)914-5259
• MDR Report Key: 24545301
• Report Number: 2024168-2026-00942
• Device Sequence Number: 20264945
• Product Code: LOX
• UDI-Device Identifier: 08717648232305
• UDI-Public: (01)08717648232305(17)271231(10)50129G1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 1400200-12
• Device Catalogue Number: 1400200-12
• Device Lot Number: 50129G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 05/12/2026; 09/24/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/14/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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