MAUDE Adverse Event Report: SUREFIRE MEDICAL, INC. SUREFIRE PRECISION INFUSION SYSTEM; INTRAVASCULAR DIAGNOSTIC CATHETER

Catalog Number	SPS-21120-35
Health Effect - Clinical Code	Ulcer (2274)
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician was using the surefire precision infusion system to deliver y90 radioembolization spheres to a tumor in the liver.Prior to infusion of the radioembolization spheres, the physician coiled the right gastric artery to prevent flow of embolics to the stomach.The surefire precision was placed distal to the coiled vessel.During infusion no slow flow or reflux of the radioembolization spheres was observed.Following the radioembolization procedure a pet ct image showed radiation activity in the antrum of the stomach.Patient was admitted to the hospital and discharged after 5 days.Endoscopy showed 2 small ulcers in the stomach.No other medical or surgical interventions were reported.Based upon discussion with the physician, user error in device positioning and appropriate device selection for the vessel size may have contributed to the event.Based upon no observation of slow flow or reflux during the procedure, the event is potentially due to a secondary unidentified vessel leading to stomach, but no images of the procedure were provided to confirm.

• Brand Name: SUREFIRE PRECISION INFUSION SYSTEM
• Common Device Name: INTRAVASCULAR DIAGNOSTIC CATHETER
• Manufacturer (Section D): SUREFIRE MEDICAL, INC.; 6272 w. 91st avenue; westminster CO 80031
• MDR Report Key: 5807624
• Report Number: 3010909876-2016-00003
• Device Sequence Number: 599436
• Product Code: DQO
• UDI-Device Identifier: 00857136004088
• UDI-Public: 00857136004088
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Catalogue Number: SPS-21120-35
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2016
• Initial Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization