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

Model Number	1400200-15
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
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 prior to use the 2x15mm nc trek neo balloon dilatation catheter (bdc) was noted to be to punctured.Therefore, the bdc was not used in the procedure.A non-abbott balloon was used to continue the procedure.There was no patient involvement and no clinically significant delay reported in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial report being filed, return device analysis found the balloon catheter was returned with blood on and in the balloon folds.The balloon was loosely folded.There was no adverse patient effect reported.The procedure was to treat a lesion in the anterior descending artery.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported puncture in the balloon was not confirmed; however, a longitudinal balloon rupture was 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 query of the complaint handling database for the reported lot revealed there is no indication of a lot of specific issue.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported punctured balloon could not be determined.Return device analysis noted that the device was returned with blood on and in the loosely folded balloon folds, which can indicate that the device was used, and a balloon rupture occurred while inside the patient anatomy.Additionally, a longitudinal balloon rupture was noted on the returned device.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, interactions with other devices or patient anatomy.In this case, it is possible that the noted balloon rupture is what was perceived as the reported puncture in the balloon; however, a conclusive cause could not be determined since limited information was provided.Correction: h6 - health effect - impact code 4656 was removed.

• 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: 23292148
• Report Number: 2024168-2025-11085
• Device Sequence Number: 13268776
• Product Code: LOX
• UDI-Device Identifier: 08717648232312
• UDI-Public: (01)08717648232312(17)270731(10)40831G1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 1400200-15
• Device Catalogue Number: 1400200-15
• Device Lot Number: 40831G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2024
• 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