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

Model Number	1400300-15
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
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 during the procedure preparation that the hub of a 3x15mm nc trek neo balloon dilatation catheter (bdc), was noted to be separated when the bdc was removed from the dispenser hoop.The bdc was replaced with another balloon catheter and the procedure was completed.There was no patient involvement nor clinical delay reported.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported hub/sidearm separation was confirmed.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.The investigation determined that the hub/sidearm separation appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.H6 correction: health effect impact code updated from 4656 to 2199 e1 correction: initial reporter: updated from (b)(6).
Event or Problem Description
Subsequent to the initially filed information, the device was received and the return analysis revealed that the use state for the device received dose not match what was reported.The balloon dilatation catheter (bdc) was returned with blood in the guide wire lumen.There was contrast in the inflation lumen.The balloon was loosely folded.It was confirmed that the separated hub was noted as the device was being advanced onto the guidewire just before entering the tuohy [valve] after being after being successfully prepared with no issues.The source of the blood was noted to be from the hands of the operators.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: 21619184
• Report Number: 2024168-2025-02716
• Device Sequence Number: 8510664
• Product Code: LOX
• UDI-Device Identifier: 08717648232527
• UDI-Public: (01)08717648232527(17)271130(10)41202G2
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 07/29/2025

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: 1400300-15
• Device Catalogue Number: 1400300-15
• Device Lot Number: 41202G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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