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

Model Number	1400350-15
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported kink was confirmed and a tear and leak in the guide wire exit notch were noted on the returned device.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, the investigation determined that the reported kink and noted tear and leak in the guide wire exit notch appear to be related to operational context.Return device analysis noted the stylet was kinked at the guide wire exit notch and the guide wire exit notch was torn distally.In this case, it is likely that the noted kink on the stylet and the tear on the notch is what the account perceived as the reported kink.It is likely that the stylet was inadvertently mishandled during unpackaging such that it became kinked and subsequently during manipulation of the kinked stylet the guide wire notch became torn.Additionally, when tested during return analysis the shaft leaked from the noted tear in the guide wire exit notch.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that during unpacking of the 3.50x15mm nc trek neo rx balloon dilatation catheter (bdc), the catheter [shaft] was kinked.There were no reports of a replacement device used.There was no patient involvement and no clinically significant delay in the procedure.Subsequently, returned device analysis observed the guidewire exit notch was torn distally for a length of 10 mm.The bdc balloon inflated and did not hold pressure and fluid was observed leaking from the guide wire inflation lumen.No additional information was provided.

• 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: 23781343
• Report Number: 2024168-2025-11975
• Device Sequence Number: 18664821
• Product Code: LOX
• UDI-Device Identifier: 08717648232633
• UDI-Public: (01)08717648232633(17)280630(10)50716G2
• 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
• Report Date (Section B): 12/11/2025

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: 1400350-15
• Device Catalogue Number: 1400350-15
• Device Lot Number: 50716G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2025
• 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