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

Model Number	1400250-25
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6- medical device problem code 1494: incorrect anatomy.
Event or Problem Description
It was reported that the procedure was to treat distal anastomosis of left femoral popliteal bypass graft with heavy calcification.The 2.5x25mm nc trek neo balloon dilatation catheter (bdc) was advanced with resistance due to the anatomy.The balloon was inflated; however, the balloon ruptured during the first inflation.When removing the bdc the balloon separated and remains in the patient.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 information received, the investigation determined that the reported balloon rupture appears to be related to user error/operational context.The reported difficulty advancing the device, the separation, foreign body in patient and serious injury/illness/impairment appear to be related to operational context.In this case, it is likely that the instruction for use (ifu) violation contributed to the reported complaints.T was reported that the procedure was to treat distal anastomosis of left femoral popliteal bypass graft.It should be noted the coronary dilatation catheters (cdc), nc trek neo, instruction for use states: the nc trek neo coronary dilatation catheters are indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infraction.Balloon dilatation of a stent after implantation (balloon models 2.00 mm ¿ 5.00 mm only).In this case, it is likely that the instruction for use (ifu) violation contributed to the reported complaint; however, an in-service will not be requested for the account since the account is aware of the violation.There was no leak noted to the balloon during preparation, which suggests a product quality issue did not contribute to the reported difficulties.It was reported by the account that the balloon dilatation catheter (bdc) interacted with the heavily calcified anatomy resulting in the reported difficulty advancing the device and subsequently the balloon became damaged and ruptured during inflation.Upon further manipulation during removal, the device ultimately separated and remains in the patient.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¿
• 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: 24584535
• Report Number: 2024168-2026-01021
• Device Sequence Number: 9121185
• Product Code: LOX
• UDI-Device Identifier: 08717648232435
• UDI-Public: (01)08717648232435(17)280531(10)50628G1
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1400250-25
• Device Catalogue Number: 1400250-25
• Device Lot Number: 50628G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown