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

Model Number	SLLES182
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While preparing for a procedure, the site found the lava-34, 2 ml package only contained syringes and was missing the lava and the dmso.The site stated it was not used for any prior cases nor was it scanned into their system for use.
Additional Manufacturer Narrative
This mdr is being submitted out of an abundance of caution.The event has the potential for serious injury should the site not have a backup device available to treat the patient.There was no reported death or serious injury.It was learned the site used a different embolic agent to complete the case and that the patient outcome was successful.The batch record was reviewed.There were (b)(4) units packaged for lot 0009000249 and no deviations or issues reported for the lot.Finished goods are inspected prior to closure of the shelf pack and there were no accountability issues with the components in the lot.Quality control personnel reviewed and signed off on the packaging event on 19 mar 2026.No other complaints have been received by sirtex for this lot.Sirtex medical affairs review this case and stated this complaint involves a lava-18, 2 ml package reported to contain only syringes, with the lava and dmso components missing.The issue was identified during inventory/preparation prior to an embolization case, before use on the patient.The site used an alternative embolic agent, the procedure was completed successfully, and the patient was reported as stable with no death or serious injury.Based on the available information, there is no evidence of patient harm; however, the event is medically relevant because missing required device components could potentially delay or prevent treatment if no backup therapy is available.The event is therefore appropriately being submitted as a reportable malfunction out of an abundance of caution.

• Brand Name: LAVA-18, 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: 25533461
• Report Number: 9710358-2026-00017
• Device Sequence Number: 13055137
• Product Code: QVG
• UDI-Device Identifier: 00850055697003
• UDI-Public: 00850055697003
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/17/2026

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: Other
• Device Model Number: SLLES182
• Device Lot Number: 0009000249
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/17/2026
• 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