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	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint stated the syringe plunger comes all the way out of the syringe and has caused lava to spill out multiple times.There was no patient harm and procedure was completed.It was suggested to have better syringes and to have different color labels for lava-18 and lava-34 as currently both are orange and are hard to differentiate.
Additional Manufacturer Narrative
This mdr has been filed out of an abundance of caution, due to a potential issue with the device which could cause a delay in procedure and/or should the event occur during a medical procedure.Review of the batch record showed the device was manufactured to released specifications and had passing quality test results.Sirtex medical affairs has review the case and has stated the reported event represents a device malfunction (syringe plunger disengagement leading to product leakage) with no patient harm and successful procedure completion.There is no evidence of clinical impact, and thus this is not an adverse event, but a device-related product quality issue.The relationship to the device is related, and the event is not serious from a patient safety perspective.Given the potential for procedural disruption if occurring during administration, the event is considered reportable as a malfunction.

• Brand Name: LAVA-34, 2 ML
• Common Device Name: Embolization Agent, Vascular
• Manufacturer (Section D): SIRTEX MEDICAL, INC.; 300 unicorn park dr; 2nd fl.; woburn MA 01801
• Manufacturer Contact: melissa sanchez ; 300 unicorn park drive; 2nd fl.; woburn, MA 01801
• MDR Report Key: 25074213
• Report Number: 9710358-2026-00015
• Device Sequence Number: 10313781
• Product Code: QVG
• UDI-Device Identifier: 00850055697027
• UDI-Public: (01)00850055697027(17)280816(10)0009000221
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: 0009000221
• 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: 04/08/2026
• Initial Report FDA Received Date: 05/04/2026
• 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