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

Model Number	SLLES182
Medical Device Problem Codes	Product Quality Problem (1506); Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No death or serious injury were reported due to the malfunction and an additional vial of lava was used to treat the patient.Sirtex learned that the customer attempted to invert the vial so the lava would drain down the side of the vial to pool at the top to draw out all the product.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.
Event or Problem Description
The customer was only able to draw 1.6 ml of the lava-18, 2 ml vial.An additional lava vial was needed to complete the procedure.No adverse event occurred to the patient.

• Brand Name: LAVA-18, 2 ML
• Common Device Name: Embolization Agent, Vascular
• Manufacturer (Section D): BLACKSWAN VASCULAR, INC.; 300 unicorn park dr; 2nd floor; woburn MA 01801
• Manufacturer Contact: melissa sanchez ; 300 unicorn park drive; floor 2; woburn, MA 01801
• MDR Report Key: 23457450
• Report Number: 9710358-2025-00015
• Device Sequence Number: 13021841
• Product Code: QVG
• UDI-Device Identifier: 00850055697003
• UDI-Public: (01)00850055697003(17)271120(10)10878
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2025

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: 10878
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/03/2025
• 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