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

Model Number	1400350-15
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
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 provided, a definitive cause for the reported balloon rupture could not be determined.In this case, it is unknown if the instructions for use (ifu) violation caused or contributed to the reported complaint.Possible factors that could contribute to balloon material ruptures include, but are not limited to, balloon damage during processing of the balloon material, insufficient preparation, inflation technique, interactions with other devices or patient anatomy.In this case, a conclusive cause for the reported balloon rupture could not be determined since the device was not returned for analysis and limited information was provided.It was reported that the device was not soaked prior to use.It should be noted that the coronary dilatation catheters (cdc), nc trek neo, instruction for use states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unknown if the instructions for use (ifu) violation caused or contributed to the reported complaint; therefore, a letter will not be requested for the account.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code: 2017 - incorrect prep.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal left anterior descending (lad) artery.The 3.5x15mm nc trek neo balloon dilatation catheter (bdc) was prepared, but not soaked prior to use.The balloon catheter was then advanced to the target lesion and the balloon was inflated; however, the balloon ruptured at nominal pressure during the first inflation.Another nc trek neo bdc was used to continue the procedure.There was no adverse patient effect reported, and no clinically significant delay reported in the procedure.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: 24845360
• Report Number: 2024168-2026-01475
• Device Sequence Number: 17539365
• Product Code: LOX
• UDI-Device Identifier: 08717648232633
• UDI-Public: (01)08717648232633(17)280831(10)50904G1
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 04/10/2026

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: 1400350-15
• Device Catalogue Number: 1400350-15
• Device Lot Number: 50904G1
• 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: 03/17/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• 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