MAUDE Adverse Event Report: SURFIRE MEDICAL INC SURFIRE INFUSION SYSTEM LT; Y90 CATHETER

Model Number SHF-38120-LT

Device Problems Occlusion Within Device (1423); Insufficient Flow or Under Infusion (2182)

Patient Problem Thrombus (2101)

Event Date 02/26/2016

Event Type  Other  

Event Description

During delivery of y90 theraspheres for treatment of liver hepatocellular carcinoma, it was discovered that pt received only about 15% of planned dose while remaining dose remained in catheter.Review with surfire rep and felt that clotting of catheter may have been a result of apparatus not fully extended, providing occlusion.

• Brand Name: SURFIRE INFUSION SYSTEM LT
• Type of Device: Y90 CATHETER
• Manufacturer (Section D): SURFIRE MEDICAL INC
• MDR Report Key: 5522256
• MDR Text Key: 41142926
• Report Number: MW5061222
• Device Sequence Number: 1
• Product Code: DQO
• 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: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: SHF-38120-LT
• Device Lot Number: 140529L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR