MAUDE Adverse Event Report: BRIVANT LIMITED VICTORY ¿; WIRE, GUIDE, CATHETER

Model Number	VICTORY 18 (300CM, 30G)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The loading came off.

• Brand Name: VICTORY ¿
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BRIVANT LIMITED; 340 lake hazeltine dr; chaska MN 55318
• MDR Report Key: 18949378
• Report Number: 18949378
• Device Sequence Number: 20602637
• Product Code: DQX
• UDI-Device Identifier: 08714729826736
• UDI-Public: (01)08714729826736
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2023
• Report Date (Section F): 11/21/2023

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: VICTORY 18 (300CM, 30G)
• Device Catalogue Number: H74939233300300
• Device Lot Number: 6763961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/21/2023