MAUDE Adverse Event Report: BLACKSWAN VASCULAR, 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	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No death or serious injury were reported due to the malfunction and it was confirmed that the patient outcome was successful using the second vial of lava.Though there was no death or serious injury in this event, a mdr has been filed due to the potential for death or serious injury due to the delay in procedure and/or should the event occur during a medical procedure.A review of production records show the batch was manufactured to approved specification and met quality assurance criteria.
Event or Problem Description
While removing air from the syringe filled with lava, the syringe plunger fell out and approximately 1 ml of lava was lost on the table.There was no patient contact and a procedural delay occurred while a new vial of lava/syringe kit was prepared.

• 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 dr, 2nd floor; woburn, MA 01801
• MDR Report Key: 23097726
• Report Number: 9710358-2025-00011
• Device Sequence Number: 8766295
• Product Code: QVG
• UDI-Device Identifier: 00850055697003
• UDI-Public: (01)00850055697003(17)270623(10)10956
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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: 10956
• 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: 08/26/2025
• Initial Report FDA Received Date: 09/19/2025
• 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