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

Catalog Number SPS-21120-35

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Ulcer (2274)

Event Type  Injury  

Event 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
• Type of Device: INTRAVASCULAR DIAGNOSTIC CATHETER
• Manufacturer (Section D): SUREFIRE MEDICAL, INC.; 6272 w. 91st avenue; westminster CO 80031
• Manufacturer (Section G): SUREFIRE MEDICAL, INC.; 6272 w. 91st avenue; westminster CO 80031
• Manufacturer Contact: lynne aronson ; 6272 w. 91st avenue; westminster, CO 80031 ; 3034261222
• MDR Report Key: 5807624
• MDR Text Key: 49947573
• Report Number: 3010909876-2016-00003
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00857136004088
• UDI-Public: 00857136004088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: SPS-21120-35
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization