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

Model Number	SLLES182
Medical Device Problem Codes	Failure to Transmit Record (1521); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A new review of this event was performed.A retrospective mdr has been filed due to the potential for serious injury out of an abundance of caution.The event did not involve death or serious injury and it was stated the patient did fine.The device labeling (ifu) states adequate fluoroscopic visualization must be maintained during lava delivery and to stop lava delivery if visualization is lost until adequate visualization is reestablished.Batch record review showed the device was manufactured to released specifications and had passing quality test results.
Event or Problem Description
Could not visual the lava under fluoroscopy.Incident occurred when the lava was injected into the target vasculature that was to be embolized.There was a branch that showed some lava on angio where the physician did not intend it to go.Patient was fine after the procedure but was going to be monitored for any complications as normal.

• Brand Name: LAVA-18, 2 ML
• Common Device Name: Embolization Agent, Vascular
• Manufacturer (Section D): BLACKSWAN VASCULAR, INC.; 709 sandoval way; hayward CA 94544
• Manufacturer Contact: melissa sanchez ; 709 sandoval way; hayward, CA 94544
• MDR Report Key: 22667933
• Report Number: 9710358-2025-00004
• Device Sequence Number: 12645701
• Product Code: QVG
• UDI-Device Identifier: 00850055697003
• UDI-Public: (01)00850055697003(17)241226(10)10631
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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 Expiration Date: 12/26/2024
• Device Model Number: SLLES182
• Device Lot Number: 10631
• 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: 12/24/2024
• Initial Report FDA Received Date: 07/30/2025
• 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