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

Model Number	1400300-15
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2025
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.B3, b6: dates estimated.
Event or Problem Description
It was reported that during an unspecified procedure, the 3.00x15mm nc trek neo balloon dilatation catheter was inflated but saline solution was leaking from the side of the catheter and the balloon ruptured.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection, functional testing, and scanning electron microscopy (sem) analysis were performed on the returned device.The reported leak was confirmed.The reported balloon ruptured was unable to be confirmed; however, the noted tear in the outer member and the reported leak is likely what was perceived as the reported balloon rupture since the balloon would not hold pressure.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.The investigation determined a potential product quality issue based on evaluation of the returned unit and the reported leak and noted tear in the outer member near guide wire exit notch.Sem analysis determined the catheter failure appears to have been caused by mechanical damage, initiated from the inner diameter (id) surface.Significant abrasion/gouging of material was found in the id surface, weakening the wall of the catheter until failure occurred.Additionally, the balloon ruptured was unable to be confirmed; however, the noted tear in the outer member and the reported leak is likely what was perceived as the reported balloon rupture since the balloon would not hold pressure.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: 23512615
• Report Number: 2024168-2025-11440
• Device Sequence Number: 9704652
• Product Code: LOX
• UDI-Device Identifier: 08717648232527
• UDI-Public: (01)08717648232527(17)280430(10)50520G2
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: 1400300-15
• Device Catalogue Number: 1400300-15
• Device Lot Number: 50520G2
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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