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

Model Number	1400250-12
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that the balloon dilation catheter interacted with the patient¿s heavily calcified, mildly tortuous, and 90% stenosed lesion, resulting in difficulty during advancement.Additionally, it was reported that the balloon ruptured during inflation.It is possible that interaction between the balloon and the patient¿s heavily calcified lesion compromised the balloons integrity, contributing to the reported material rupture.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous, heavily calcified de novo left anterior descending artery that was 90% stenosed.Preparation was performed per the instructions for use without issue.Reportedly, the 2.50x12 mm trek balloon was used for post-dilatation, but the balloon ruptured during the first inflation at 10 atmospheres.There was resistance during advancement with the anatomy.Another balloon was used to successfully complete the procedure.There were no adverse patient effects and there was no reported 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19954045
• Report Number: 2024168-2024-09453
• Device Sequence Number: 8967432
• Product Code: LOX
• UDI-Device Identifier: 08717648232404
• UDI-Public: (01)08717648232404(17)260630(10)30719G1
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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: 06/30/2026
• Device Model Number: 1400250-12
• Device Catalogue Number: 1400250-12
• Device Lot Number: 30719G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2023
• 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