MAUDE Adverse Event Report: LAKE REGION MEDICAL VICTORY 12G 300-018

Model Number	901063-20
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Heavily calcified cto of pop.Tried from above and below.While trying to stay true lumen and struggling to find any calcium channels the physician asked for a 12-gram tip victory.18 wire.While trying to wire the cto the tip of the wire became disconnected from the body of the wire.There were no patient complications, and the case was completed successfully.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue? wire was removed what is the next course of action? second wire was removed 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
Heavily calcified cto of pop.Tried from above and below.While trying to stay true lumen and struggling to find any calcium channels the physician asked for a 12-gram tip victory.18 wire.While trying to wire the cto the tip of the wire became disconnected from the body of the wire.There were no patient complications, and the case was completed successfully.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: wire was removed what is the next course of action?: second wire was removed patient present at time of event?: yes patient complications: no patient complications.

• Brand Name: VICTORY 12G 300-018
• Common Device Name: VICTORY 12G 300-018
• 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; ireland H91 C K22; EI H91 CK22
• Manufacturer Contact: amy carter ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 20555266
• Report Number: 3006010712-2024-00045
• Device Sequence Number: 3114442
• Product Code: DQX
• UDI-Device Identifier: 00816349012457
• UDI-Public: (01)00816349012457(11)240507(17)270430(10)8986044
• 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): 11/05/2024

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 Model Number: 901063-20
• Device Catalogue Number: H74939472300120
• Device Lot Number: 8986044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2024
• 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