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

Model Number 901023-22

Device Problems Flaked (1246); Peeled/Delaminated (1454)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/23/2022

Event Type  malfunction  

Event Description

It was reported that wire victory 14 can be pushed out from rubicon 14 catheter, when its removed outside it turns out that there a chipped layer of victory in the middle of the wire.

Manufacturer Narrative

Complaint investigation underway and will be attached to this report.

Event Description

It was reported that; wire victory 14 can be pushed out from rubicon 14 catheter, when its removed outside it turns out that there a chipped layer of victory in the middle of the wire.

Manufacturer Narrative

Complaint investigation underway and will be attached to this report.

• Brand Name: VICTORY 14 (300CM, 18G)
• Type of Device: VICTORY 14 (300CM, 18G)
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91CK 22; EI H91CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; parkmore west business park; galway, H91CK 22; EI H91CK22
• Manufacturer Contact: krishna priya kodumadu venkittaraman ; parkmore west business park; galway, H91CK-22 ; EI H91CK22
• MDR Report Key: 15549300
• MDR Text Key: 304730092
• Report Number: 3006010712-2022-00044
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729826613
• UDI-Public: 08714729826613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2022

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
• Device Operator: Health Professional
• Device Model Number: 901023-22
• Device Catalogue Number: H74939230300180
• Device Lot Number: 6565451
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1