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

Model Number	1400350-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat an unspecified in-stent restenosis in the left anterior descending artery.The 3.5x20mm nc trek neo balloon dilatation catheter was used for dilatation and advanced with no resistance.The balloon was inflated once to just above rated burst pressure when a rupture occurred.Resistance was noted during withdrawal, no force was applied.A non-abbott nc balloon was used to continue the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.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.It was reported that the balloon was inflated once to just above rated burst pressure when a rupture occurred.It should be noted that the coronary dilatation catheters (cdc), nc trek neo, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek neo device is 18 atm; therefore, rbp was exceeded.It could not be determined if inflating the balloon slightly over the rated burst pressure contributed to the rupture.Based on the information provided, a definitive cause for the reported balloon rupture could not be determined; however, the reported difficulty removing the device appears to be related to operational context.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, 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.Additionally, it is likely that the reported difficulty removing the device from the anatomy resulted from the balloon ruptured material interacting with the anatomy as the balloon probably did not refold as normal due to the balloon rupture.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 - over-expansion.

• 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21101003
• Report Number: 2024168-2025-00294
• Device Sequence Number: 8934819
• Product Code: LOX
• UDI-Device Identifier: 08717648232640
• UDI-Public: (01)08717648232640(17)270531(10)40611G1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 01/08/2025

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: 1400350-20
• Device Catalogue Number: 1400350-20
• Device Lot Number: 40611G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED STENT
• Patient Sex: Unknown