MAUDE Adverse Event Report: LAKE REGION MEDICAL VICTORY 12G 300-014

Model Number	901063-18
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Left to right contralateral access.Cto in the right proximal/mid at.Physician had legacy rubicon proximal to lesion.When attempting to cross the wire, the tip looked like it was going to fracture.Physician pulled wire before tip completely fractured.He then pulled a victory 14 30g tip and was unable to cross cto.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue? none, removed wire before tip completely fractured.What is the next course of action? na.Replace for customer.Patient present at time of event? yes, patient complications: no patient complications.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
Left to right contralateral access.Cto in the right proximal/mid at.Physician had legacy rubicon proximal to lesion.When attempting to cross the wire, the tip looked like it was going to fracture.Physician pulled wire before tip completely fractured.He then pulled a victory 14 30g tip and was unable to cross cto.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: none, removed wire before tip completely fractured.What is the next course of action?: na.Replace for customer.Patient present at time of event?: yes, patient complications: no patient complications.
Additional Manufacturer Narrative
Complaint investigation has been completed as part of this report.

• Brand Name: VICTORY 12G 300-014
• Common Device Name: VICTORY 12G 300-014
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, ; EI
• Manufacturer (Section G): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: barbara krason ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 22402796
• Report Number: 3006010712-2025-00029
• Device Sequence Number: 21255889
• Product Code: DQX
• UDI-Device Identifier: 00816349012372
• UDI-Public: (01)00816349012372(11)240422(17)270331(10)8935379
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: 901063-18
• Device Catalogue Number: H74939470300120
• Device Lot Number: 8935379
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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