MAUDE Adverse Event Report: TRISALUS LIFE SCIENCES TRINAV INFUSION SYSTEM

Model Number TNV-21120-35

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 07/01/2020

Event Type  Injury  

Event Description

Stereostatic body radiation therapy utilizing y-90 to the liver with a suture-fire (one-way) catheter.Radiation found in stomach / esophagus.Subsequently the pt developed severe gastritis / esophagitis leading stereotactic body radiation therapy utilizing y-90 to the liver with a sure-fire (one-way) catheter.Radiation found in stomach / esophagus.Subsequently the pt developed severe gastritis/esophagitis leading to radiation gastritis and radiation ulcerations.Pt needed a laparoscopic jejunostomy feeding tube placement for caloric intake on (b)(6) 2020.

• Brand Name: TRINAV INFUSION SYSTEM
• Type of Device: TRINAV INFUSION SYSTEM
• Manufacturer (Section D): TRISALUS LIFE SCIENCES; 6272 w. 91st avenue
• MDR Report Key: 10642554
• MDR Text Key: 211027980
• Report Number: 10642554
• Device Sequence Number: 1
• Product Code: DQO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TNV-21120-35
• Device Lot Number: 200107C
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 09/15/2020
• Event Location: Hospital
• 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): Disability
• Patient Age: 63 YR