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

Model Number	1400350-12
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported difficulty could not be replicated in a testing environment due to the condition of the returned device.Return device analysis noted a separation proximal to the support skive/wire/bayonet.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 reported information and the observations from the returned analysis, a definitive cause for the reported difficulty or noted separation on the returned device could not be determined.Possible factors that can contribute to difficulty removing the mandrel/stylet may include, but not limited to, damage during protective sheath removal, removal technique or mishandling.In this case a conclusive cause for the reported complaint could not be determined since limited information was provided and the complete device and component were not returned for analysis.Possible factors that may contribute to a separation may include, but not limited to, inadvertent mishandling of the device, interaction with the anatomy and/or physician applies excessive force against resistance.In this case, a conclusive cause for the noted separation could not be determined since limited information was provided and no additional information was provided during follow up.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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 the stylet of the 3.5x12mm nc trek neo balloon dilatation catheter (bdc) was not able to be removed from the bdc; therefore, the bdc was not used in the procedure.There was no patient involvement 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: 21191472
• Report Number: 2024168-2025-00683
• Device Sequence Number: 17004654
• Product Code: LOX
• UDI-Device Identifier: 08717648232626
• UDI-Public: (01)08717648232626(17)260930(10)31025G1
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 03/25/2025

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: 09/30/2026
• Device Model Number: 1400350-12
• Device Catalogue Number: 1400350-12
• Device Lot Number: 31025G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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