MAUDE Adverse Event Report: BRIVANT LTD. T/A LAKE REGION MEDICAL VICTORY 18 (195CM 30G)

Model Number 901023-31

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Type  malfunction  

Manufacturer Narrative

Complaint investigation underway.

Event Description

It was reported that the wire tip broke in occluded portion of vessel.

Event Description

It was reported that the wire tip broke in occluded portion of vessel.

Manufacturer Narrative

Complaint investigation underway and will be attached to this report.

• Brand Name: VICTORY 18 (195CM 30G)
• Type of Device: VICTORY 18 (195CM 30G)
• Manufacturer (Section D): BRIVANT LTD. T/A LAKE REGION MEDICAL; parkmore west business park; galway, EI ; EI EI
• MDR Report Key: 9368696
• MDR Text Key: 207953246
• Report Number: 3006010712-2018-00040
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K120137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 901023-31
• Device Catalogue Number: H74939233195300
• Device Lot Number: 4870096
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other