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

Model Number	1400275-15
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.Return device analysis noted a tear/hole on the outer member proximal to the guide wire exit notch, there was an unknown green foreign material on the inflation lumen adjacent to the noted tear and there were bends in the hypotube.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 noted a tear/hole on the outer member proximal to the guide wire exit notch and the unknown green foreign material on the inflation lumen adjacent to the noted tear could not be determined.The investigation determined the noted bends in the hypotube appear to be related to operational context.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional devices referenced in b5 are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that two 2.75x15mm non-compliant (nc)trek neo balloon dilatation catheters (bdc) were noted to be broken yet not separated in the packaging with no damage noted to the packaging.They were not used.Another nc trek bdc was used to continue the procedure.There was no patient involvement and no reported clinically significant delay in procedure.Returned device analysis identified that a third device was used and there was a tear proximal to the guide wire exit notch and an unknown green foreign material on the inflation lumen adjacent to the noted tear.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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21107347
• Report Number: 2024168-2025-00356
• Device Sequence Number: 20871320
• Product Code: LOX
• UDI-Device Identifier: 08717648232473
• UDI-Public: (01)08717648232473(17)260930(10)31019G1
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 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 Expiration Date: 09/30/2026
• Device Model Number: 1400275-15
• Device Catalogue Number: 1400275-15
• Device Lot Number: 31019G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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