MAUDE Adverse Event Report: RADIOMED CORPORATION VISICOIL GOLD FIDUCIAL MARKER; SOURCE, BRACHYTHERAPY, RADIONUCLIDE

Lot Number 211117-44

Device Problems Mechanical Jam (2983); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2022

Event Type  malfunction  

Event Description

Marker did not deploy from the needle, marker seemed to have been stuck in the needle.

• Brand Name: VISICOIL GOLD FIDUCIAL MARKER
• Type of Device: SOURCE, BRACHYTHERAPY, RADIONUCLIDE
• Manufacturer (Section D): RADIOMED CORPORATION; 3150 stage post drive, suite 106; bartlett TN 38133
• MDR Report Key: 14601136
• MDR Text Key: 293357608
• Report Number: 14601136
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 211117-44
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2022
• Event Location: Other
• Date Report to Manufacturer: 06/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Race: Black Or African American