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

Model Number	SLLES182
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A new review of this event was performed.A retrospective mdr has been filed out of an abundance of caution due to the potential for serious injury.Batch record review showed the device was manufactured to released specifications and passing quality test results.
Event or Problem Description
Two vials (one - 2 ml vial of lava-18 and one-2 ml vial of lava 34) were placed on the small vortex adapter and the vortex mixer was turned on at the appropriate speed.About 12 minutes after the vials were placed on the mixer, it made a loud noise and the lava-18 vial came off of the vortex.The sterile blue cap was knocked off and was not used and the other vial was for administration.Before placing the vial on the vortex to complete the mixing, the unaffected vial was taped to the adapter.

• 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: 22667845
• Report Number: 3005579300-2025-00002
• Device Sequence Number: 3825238
• Product Code: QVG
• UDI-Device Identifier: 00850055697003
• UDI-Public: (01)00850055697003(17)241202(10)10618
• 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): 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: 12/02/2024
• Device Model Number: SLLES182
• Device Lot Number: 10618
• 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: 06/26/2024
• 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