MAUDE Adverse Event Report: CIVCO CIVCO STAND OFF BALLOON; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Device Problems Leak/Splash (1354); Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Anxiety (2328)

Event Date 12/15/2020

Event Type  malfunction  

Event Description

During a spaceoar placement procedure performed for radioactive therapy protection by dr.(b)(6) on (b)(6) 2020, "probe inserted, visualization occurred.Needle for anesthesia, filling balloon for improved visibility, noticed balloon was out of water and not holding fluid.Procedure stopped." additional information was received on january 6, 2021 stated, "this was not a bsc stand off balloon, the procedure was completed.This procedure was done under local anesthesia.This was a civco stand off balloon." stand off balloon failure, unable to determine of needle puncture, abundance of caution, aborted the procedure.Reschedule for or, patient very anxious in a conscious setting.Standoff safety balloon failure caused room concern from a rectal wall hit standpoint.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CIVCO STAND OFF BALLOON
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): CIVCO
• MDR Report Key: 17525176
• MDR Text Key: 321141821
• Report Number: MW5132118
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1