MAUDE Adverse Event Report: CIANNA MEDICAL; SAVI APPLICATOR

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 02/03/2014

Event Type  Injury  

Event Description

Patient was scheduled for her last radiation treatment using the savi applicator.Applicator had been surgically placed in the pt on (b)(6) 2014.Pt was then scheduled to receive 10 treatments, twice a day.Her last treatment was (b)(6) 2014 and following the treatment the savi applicator was to be removed.The physician tried for 30 minutes to remove the savi applicator.It was presumed that scar tissue was adhering to the lumens of the catheter.The (b)(4) rep was present and tried to pull the catheter out and it broke apart.Pt was sent to surgeon's office the next day (b)(6) 2014 and another (b)(4) rep was present.The surgeon injected lidocaine into the cavity and used a hemostat to easily remove it.

• Type of Device: SAVI APPLICATOR
• Manufacturer (Section D): CIANNA MEDICAL
• MDR Report Key: 3645470
• MDR Text Key: 4355983
• Report Number: MW5034674
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR