MAUDE Adverse Event Report: CIANNA MEDICAL SAVI; BREAST CATHETER

Model Number 8-1

Device Problem Positioning Failure (1158)

Patient Problem Radiation Underdose (2166)

Event Date 05/16/2014

Event Type  malfunction  

Event Description

A savi breast catheter used for accelerated partial breast irradiation had 2 struts (#2 and 9) that failed to deploy in the pt's breast.As a result of the malfunction the catheter was removed and treatment for breast cancer was delayed.This is the third savi apbi breast catheter in the last 90 days that has failed to perform as intended.

• Brand Name: SAVI
• Type of Device: BREAST CATHETER
• Manufacturer (Section D): CIANNA MEDICAL; aliso viejo CA 92656
• MDR Report Key: 3835670
• MDR Text Key: 4502485
• Report Number: MW5036260
• Device Sequence Number: 1
• Product Code: JAQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8-1
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other