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

Model Number	1400275-15
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the shaft of the 2.75x15mm nc trek neo balloon dilatation catheter broke during insertion into the lesion.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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
Subsequent to the previously filed report, additional information was received: the nc trek neo balloon dilatation catheter was advanced with resistance and the shaft became kinked, it did not break.Another abbott balloon dilatation catheter was used to continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported kink was confirmed.The reported difficulty to advance could not be replicated in a testing environment as it was based on operational circumstances.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 difficulty advancing the device could not be determined; however, the reported kink appears to be related to operational context.Potential factors that could contribute to difficulty advancing the device include, but are not limited to, patient anatomy, pre-dilatation strategy, device placement technique, and accessory device support.In this case, since limited information was provided, a conclusive cause for the reported difficulty cannot be determined.Additionally, it is likely that the balloon dilatation catheter kinked during advancement as difficulty was encountered.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5: describe event or problem: updated.H6: device code 1069 was removed, 2889 and 2920 were added.

• 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20935512
• Report Number: 2024168-2024-14742
• Device Sequence Number: 15539421
• Product Code: LOX
• UDI-Device Identifier: 08717648232473
• UDI-Public: (01)08717648232473(17)260930(10)31019G1
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 02/12/2025

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 Expiration Date: 09/30/2026
• Device Model Number: 1400275-15
• Device Catalogue Number: 1400275-15
• Device Lot Number: 31019G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 12/15/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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