MAUDE Adverse Event Report: SIRTEX MEDICAL, INC. LAVA-18, 2 ML; Embolization Agent, Vascular

Model Number	SLLES182
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a peripheral embolization procedure, the physician and ir staff were unable to fully extract the labeled 2.0 ml volume from a lava 2 ml vial.Despite following standard preparation steps and employing commonly used techniques to maximize vial extraction, only approximately 1.5 ml of product could be withdrawn.The physician required the full 2.0 ml to complete the planned embolization.Due to the insufficient retrievable volume, the physician was required to transition to an alternative embolic agent to complete the procedure.This resulted in: additional procedural time, use of an additional embolic device, and increased procedural cost to the facility.No user error was identified by the physician or staff during preparation or extraction.The physician suggested considering filling the vial with the full labeled 2.0 ml or a slight overfill to ensure that the full 2.0 ml can be consistently withdrawn into syringes for delivery during procedures.There was no negative outcome to the patient.
Additional Manufacturer Narrative
No death or serious injury were reported due to the malfunction and the physician transitioned to an alternative embolic agent to complete the procedure.Though there was no death or serious injury in this event, a mdr has been filed out of an abundance of caution, due to the potential for death or serious injury of uncontrolled hemorrhage if the malfunction caused the patient to not be treated or for the delay in procedure.Batch record review showed the device was manufactured to released specifications and had passing quality test results.Sirtex has confirmed that the device will not be returned for further investigation.

• 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: 24561313
• Report Number: 9710358-2026-00006
• Device Sequence Number: 18524544
• Product Code: QVG
• UDI-Device Identifier: 00850055697003
• UDI-Public: (01)00850055697003(17)280816(10)9000221
• 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): 03/10/2026

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: 9000221
• 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: 02/11/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown