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

Model Number	1012451-15
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	11/07/2025
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 violations of the instructions for use (ifu) caused or contributed to the reported complaint.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, ifu states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.Also, the device was not prepared (air aspiration) outside the anatomy.It should be noted that the cdc, nc trek rx, global, ifu specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.Possible factors that could contribute to balloon material ruptures include, but are not limited to, balloon damage during processing of the balloon material, inflation technique, insufficient prep, interactions with other devices or lesion calcification.In this case, a conclusive cause could not be determined since the device was not retuned for analysis and limited information was provided.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: failure to follow steps / instructions.
Event or Problem Description
It was reported this was a procedure to treat a mildly tortuous and 99% stenosed right coronary artery.An nc trek rx 3.50x15mm balloon delivery catheter (bdc) was inserted and inflated to 12-14atm.However, a pressure leak was detected, and upon inspection, a balloon rupture was observed.Therefore, the bdc was removed without further issues and replaced with another nc trek.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: NC TREK
• 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: 23822717
• Report Number: 2024168-2025-12109
• Device Sequence Number: 9974568
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: (01)08717648151989(17)271031(10)41128G2
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103153
• 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): 12/16/2025

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: 1012451-15
• Device Catalogue Number: 1012451-15
• Device Lot Number: 41128G2
• 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: 12/01/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2024
• 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