MAUDE Adverse Event Report: BLACKSWAN VASCULAR, INC. LAVA-34, 2 ML; Embolization Agent, Vascular

Model Number	SLLES342
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Lava was not visible under fluoro.Vial was on the vortex for 8 mins then hand mixed with the mixing kit for 30 passes.
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.The event did not involve death or serious injury and it was confirmed that the physician stated the patient's vessel seemed occluded.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.

• Brand Name: LAVA-34, 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: 22668028
• Report Number: 9710358-2025-00005
• Device Sequence Number: 3716667
• Product Code: QVG
• UDI-Device Identifier: 00850055697010
• UDI-Public: (01)00850055697010(17)261202(10)10938
• 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 Model Number: SLLES342
• Device Lot Number: 10938
• 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: 06/05/2025
• Initial Report FDA Received Date: 07/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown