MAUDE Adverse Event Report: SIRTEX MEDICAL, INC. LAVA-34, 2 ML; Embolization Agent, Vascular

Model Number	SLLES342
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event did not involve death or serious injury and it was confirmed that the physician was able to complete the case with another vial that did not break.(b)(6), inc.Is not the manufacturer of the vortex mixer.Proper mixing of the lava device is integral for its intended use.This mdr has been filed out of an abundance of caution due to the potential for serious injury should the lava device not be properly mixed.(b)(6) affairs has stated the overall benefit-risk profile of the lava system remains unchanged, and this event does not alter the safety profile of the device.
Event or Problem Description
The vortex mixer and attachment used in this event did not securely hold the vial of lava causing it to come off the mixer and break.Proper mixing of the lava device is integral for its intended use.Sirtex medical, inc.Is not the manufacturer of the vortex mixer or the attachment.

• Brand Name: LAVA-34, 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: 24802619
• Report Number: 9710358-2026-00011
• Device Sequence Number: 10682656
• Product Code: QVG
• UDI-Device Identifier: 00850055697010
• UDI-Public: 00850055697010
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 04/07/2026

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: SLLES342
• Device Lot Number: 10959
• Was Device Available for Evaluation?: No
• 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: 03/11/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown