MAUDE Adverse Event Report: RADIOMED CORPORATION VISICOIL

Model Number VC-035-020-PL

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 06/07/2017

Event Type  Injury  

Event Description

Md attempted to place the bilateral fiducial gold marker into the prostate through a needle but it was jammed and would not advance into the site after multiple attempts.

• Brand Name: VISICOIL
• Type of Device: VISICOIL
• Manufacturer (Section D): RADIOMED CORPORATION
• MDR Report Key: 6676671
• MDR Text Key: 78908813
• Report Number: MW5070703
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: VC-035-020-PL
• Device Lot Number: 160617-87
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR