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

Model Number SLLES186

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

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 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.".

• Brand Name: LAVA-18, 6 ML
• Type of Device: 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
• MDR Text Key: 336759169
• Report Number: 3015355651-2024-00001
• Device Sequence Number: 1
• Product Code: QVG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P220020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SLLES186
• Device Lot Number: 10518
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1