MAUDE Adverse Event Report: SIRTEX MEDICAL, INC. LAVA-18, 2 ML; EMBOLIZATION AGENT, VASCULAR

Model Number	SLLES182
Medical Device Problem Codes	Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on-going and an update will be provided on the next report.
Event or Problem Description
The customer was unable to visualize the lava under the fluoroscope.The lava was mixed using a vortex mixer for 5 minutes and then using the mixing kit for 16 passes.The customer knew the embolization worked as they put some contrast through the base catheter.

• Brand Name: LAVA-18, 2 ML
• Common Device Name: EMBOLIZATION AGENT, VASCULAR
• Manufacturer (Section D): SIRTEX MEDICAL, INC.; 300 unicorn park dr.; fl. 2; woburn MA 01801
• Manufacturer Contact: melissa sanchez ; 300 unicorn park drive; fl. 2; woburn, MA 01801
• MDR Report Key: 24323464
• Report Number: 9710358-2026-00002
• Device Sequence Number: 9541998
• Product Code: QVG
• UDI-Device Identifier: 00850055697003
• UDI-Public: (01)00850055697003(17)280503(10)10906
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SLLES182
• Device Lot Number: 10906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown