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

Model Number	1400300-20
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Failure to Deflate (4060)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2026
Type of Reportable Event	Death
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
It was reported that during a procedure to treat a heavily calcified right coronary artery, a perforation occurred.The 3.0 x 20mm nc trek neo balloon dilatation catheter (bdc) was used to treat the perforation successfully; however, the balloon completely failed to deflate.The back stiff end of an unspecified guide wire was used in an attempt to pop the balloon but was unsuccessful.An attempt to snare the balloon was made, but also unsuccessful.Another attempt to pop the balloon was made by cutting the backside of the bdc shaft; however, this was also unsuccessful.The patient was to be transferred to the operating room; however, died during transport.In the physician opinion, the failure to deflate the balloon was due to interaction of the possibly kinked shaft and calcium and contributed to the death.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 query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.A medical review was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that this was a case to treat an 80-year-old female with prior medical history of coronary arterial disease (cad).Post atherectomy using a non-abbott device revealed a perforation.The physician treated the perforation with balloon tamponade using the 3.0 x 20mm nc trek neo balloon dilatation catheter.The nc trek neo was able to successfully treat the perforation.The physician had trouble deflating the balloon and tried several techniques to achieve deflation.The inflated balloon necessitated emergency surgery; however, the patient expired during transportation.Based on the information received, the investigation determined that the reported issues appears to be related to operational context in this case, the device was not returned for analysis.The attending physician stated that the reported failure to deflate could be related to a possible kinked shaft and interaction with the patient¿s anatomy.It is possible that handling and/or manipulation of the device after insertion resulted in a shaft kink.The kinked shaft and/or heavily calcified anatomy likely caused a narrowed/restricted inflation lumen resulting in the reported failure to deflate.Multiple attempts were made to deflate the device.These attempts were unsuccessful, resulting in the foreign body in patient.The cause of death cannot be attributed to the use of the 3.0 x 20mm nc trek neo balloon dilatation catheter (bdc).However, it is reasonable to state that the nc trek neo was an indirect contributor to adverse events based on operational context of the procedure.The reported patient effect of death is listed in the coronary dilatation catheters (cdc), nc trek neo, instruction for use as a known patient effect.Based on the results of the complaint investigation, 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: 24210852
• Report Number: 2024168-2026-00404
• Device Sequence Number: 20217290
• Product Code: LOX
• UDI-Device Identifier: 08717648232534
• UDI-Public: (01)08717648232534(17)280930(10)51017G1
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/27/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1400300-20
• Device Catalogue Number: 1400300-20
• Device Lot Number: 51017G1
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2025
• 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: Required Intervention; Death
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White