MAUDE Adverse Event Report: NEW WORLD MEDICAL, INC. VIA360 SURGICAL SYSTEM; INFUSION PUMP

Model Number	VIA 360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ifu for the reported product model was reviewed and confirmed to include precautions related to handling of the cannula and microcatheter, as improper handling may result in kinking or damage.The device history record for the reported lot was reviewed, and no issues were identified.The product was manufactured, tested, and released in accordance with validated procedures.The returned device was visually inspected and confirmed to have a cut at the catheter tip.The condition is consistent with handling-related damage that may occur if the cannula contacts or exerts stress on the microcatheter during use.
Event or Problem Description
The catheter tip broke off in the canal during trabeculotomy.

• Brand Name: VIA360 SURGICAL SYSTEM
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer (Section G): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer Contact: cristina avalos ; 10763 edison court; rancho cucamonga, CA 91730 ; 9094664304
• MDR Report Key: 23475775
• Report Number: 1000125279-2025-00044
• Device Sequence Number: 10227697
• Product Code: HMZ
• UDI-Device Identifier: 00892064002362
• UDI-Public: (01)00892064002362(11)250703(17)260703(10)G1625
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K243503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2026
• Device Model Number: VIA 360
• Device Catalogue Number: VIA 360
• Device Lot Number: G1625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown