MAUDE Adverse Event Report: BLACKSWAN VASCULAR, INC. LAVA-18, 6 ML; LAVA LIQUID EMBOLIC SYSTEM

Model Number	SLLES186
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturing data and other details are currently being evaluated to determine root cause.It is not currently known whether the incident occurred due to device malfunction or other cause(s).There was no adverse impact to patient.
Event or Problem Description
Physician was using a 6 ml lava vial for an off label use and could only get 5.0 ml out of the vial.Different angles and needles were tried to get the lava out, but physician could not get any more product out of the vial.Physician completed procedure by using coils since no additional lava product was available on site.Patient was not affected.The report states, "patient did fine.".
Event or Problem Description
Physician was using a 6 ml lava vial for an off label use and could only get 5.0 ml out of the vial.Different angles and needles were tried to get the lava out, but physician could not get any more product out of the vial.Physician completed procedure by using coils since no additional lava product was available on site.Patient was not affected.The report states, "patient did fine.".
Additional Manufacturer Narrative
The device history records (dhr) review showed no abnormalities and that the product met the production acceptance criteria per established manufacturing production instructions.The records also show that the sub-assembly production parts met the requirements and specifications per established manufacturing requirements, such as sterilization & verification by analytical laboratory and viscosity measurement.The product lot passed visual inspections of the les serum vials and passed the leak test.The device was not returned, so no further investigation can be completed.

• Brand Name: LAVA-18, 6 ML
• Common Device Name: LAVA LIQUID EMBOLIC SYSTEM
• Manufacturer (Section D): BLACKSWAN VASCULAR, INC.; 709 sandoval way; hayward CA 94544
• Manufacturer Contact: vana poovala ; 709 sandoval way; hayward, CA 94544 ; 8884747839
• MDR Report Key: 18793552
• Report Number: 3015355651-2024-00001
• Device Sequence Number: 7231338
• Product Code: QVG
• UDI-Device Identifier: 00850055697027
• UDI-Public: 850055697027
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P220020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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: SLLES186
• Device Lot Number: 10518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 06/05/2024
• 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