MAUDE Adverse Event Report: CIANNA MEDICAL SAVI 8-1 CATHETER; BREAST CATHETER

Model Number SAVI 8-1

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

Savi 8-1 breast catheter device has two obstructed channels that would not allow the passage of the hdr source to deliver planned radiation dose for breast cancer treatment.The treatment plan was rerun eliminating the two obstructed channels.A satisfactory radiation dose distribution was achieved using the remaining channels.The treatment was delayed one day due to this problem.Reason for use: breast cancer.

• Brand Name: SAVI 8-1 CATHETER
• Type of Device: BREAST CATHETER
• Manufacturer (Section D): CIANNA MEDICAL; aliso viejo CA 92656
• MDR Report Key: 3629195
• MDR Text Key: 4181775
• Report Number: MW5034481
• 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: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SAVI 8-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1