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

Model Number	1400250-06
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
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 difficulty could not be determined.Possible factors that may contribute to resistance with the guide wire may include, but are not limited to, device placement technique, introducer sheath support, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, or damage to the distal shaft of the catheter.A conclusive cause for the reported complaint could not be determined since the device or component were not returned for analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported the procedure was to treat a moderately calcified and mildly tortuous lesion in the distal left anterior descending (lad) artery.The ht turntrac guide wire (gw) was advanced to the target lesion followed by advancement of a 2.50x06mm nc trek neo balloon dilatation catheter (bdc).After inflating the balloon to 12 atmospheres (atm), upon attempting to withdraw the bdc, resistance was met and the devices were stuck together.The gw was unintentionally pulled out along with the bdc.After removal, an attempt was made to separate the balloon from the guidewire outside the anatomy, but it could not be detached.A versaturn gw was used to re-cross the lesion, and a new nc trek neo of the same size was opened and used for additional inflation.A 2.50x15mm xience stent was then deployed, completing the procedure.There were no adverse patient effects and no clinically significant delay 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 00000 ; CS 00000
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22131050
• Report Number: 2024168-2025-05647
• Device Sequence Number: 20694350
• Product Code: LOX
• UDI-Device Identifier: 08717648232381
• UDI-Public: (01)08717648232381(17)260831(10)30914G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/03/2025

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 Expiration Date: 08/31/2026
• Device Model Number: 1400250-06
• Device Catalogue Number: 1400250-06
• Device Lot Number: 30914G1
• 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: 05/26/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2023
• 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