MAUDE Adverse Event Report: CIANNA MEDICAL SAVI-08; SAVI BRACHYTHERAPY CATHETER

Model Number REF # SAVI-08

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 12/08/2017

Event Type  Injury  

Event Description

Savi catheter inserted (b)(6) 2017.On (b)(6) 2017 failed explant of savi device removal from breast.The coupling disengaged between the central catheter and the device, so the device could not be deflated.Pt had to return to the operating room for removal on (b)(6) 2017.

• Brand Name: SAVI-08
• Type of Device: SAVI BRACHYTHERAPY CATHETER
• Manufacturer (Section D): CIANNA MEDICAL; aliso viejo CA
• MDR Report Key: 7138499
• MDR Text Key: 95620552
• Report Number: MW5074154
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF # SAVI-08
• Device Catalogue Number: PMM ITEM # 39941
• Device Lot Number: ML03044
• 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: 56 YR