MAUDE Adverse Event Report: LAKE REGION MEDICAL VICTORY 14 (300CM, 18G)

Model Number	901023-22
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
The doctors were trying to access the anterior tibial artery from the popliteal artery and weren´t able to.They took out the victory guidewire out of the balloon to insert another wire when they noticed that the tip of the victory guidewire was stuck in the hub.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: they tried to dislodge the stuck tip by injecting saline solution into the balloon and also push it with another guidewire.What is the next course of action?: none patient present at time of event?: yes patient complications: no patient complications device acquired from a distributor?: no.
Additional Manufacturer Narrative
Complaint investigation report is attached to this report.
Event or Problem Description
The doctors were trying to access the anterior tibial artery from the popliteal artery and weren´t able to.They took out the victory guidewire out of the balloon to insert another wire when they noticed that the tip of the victory guidewire was stuck in the hub.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: they tried to dislodge the stuck tip by injecting saline solution into the balloon and also push it with another guidewire.What is the next course of action?: none patient present at time of event?: yes patient complications: no patient complications device acquired from a distributor?: no.

• Brand Name: VICTORY 14 (300CM, 18G)
• Common Device Name: VICTORY 14 (300CM, 18G)
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; parkmore west business park; galway, H91CK 22; EI H91CK22
• Manufacturer Contact: jaseem saqib ; parkmore west business park; galway, H91CK-22 ; EI H91CK22
• MDR Report Key: 18473711
• Report Number: 3006010712-2023-00060
• Device Sequence Number: 6885600
• Product Code: DQX
• UDI-Device Identifier: 08714729826613
• UDI-Public: 08714729826613
• 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): 03/25/2024

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: 12/31/2025
• Device Model Number: 901023-22
• Device Catalogue Number: H74939230300180
• Device Lot Number: 7846619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2023
• 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