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

Model Number	1400250-15
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in an unknown vessel.During use with the 2.5x15mm nc trek neo balloon dilatation catheter (bdc), it was noted that only 1 radiopaque marker was visible; therefore, it was unable to be sized.The bdc was removed and the procedure was continued with the use of another bdc.There were no adverse patient effects nor clinically significant delay.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.D4: a partial udi was provided as the lot number is not known.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported missing balloon marker was 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 evaluation of the returned device, a potential product quality issue has been identified for the reported and confirmed missing balloon marker.A corrective and preventative actions (capa) has been initiated to further investigate the potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 22885640
• Report Number: 2024168-2025-08982
• Device Sequence Number: 4864610
• Product Code: LOX
• UDI-Device Identifier: 08717648232411
• UDI-Public: (01)08717648232411(17)280430(10)50509G1
• 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
• Report Date (Section B): 10/22/2025

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: 1400250-15
• Device Catalogue Number: 1400250-15
• Device Lot Number: 50509G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• 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