MAUDE Adverse Event Report: KANEKA CORPORATION LIPOSORBER; LA-15

Model Number	LA-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Stenosis (2263); Intracranial Pressure Increased (4586)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
[diagnosis]: intracranial hypertension.[description]: patient was admitted on (b)(6) 2025 for worsening headaches and concern for increased intracranial pressure.Patient found to have stenosis of the distal right transverse sinus stent.Pt.Hospitalized and balloon angioplasty of right transverse sinus distal stent stenosis performed on (b)(6) 2025.Patient was released from hospital on (b)(6) 2025.

• Brand Name: LIPOSORBER
• Common Device Name: LA-15
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18 nakanoshima, kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• MDR Report Key: 22370292
• Report Number: 2435151-2025-00009
• Device Sequence Number: 14562262
• Product Code: PBN
• UDI-Device Identifier: 24993478010117
• UDI-Public: (01)24993478010117(17)260128(10)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section F): 07/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LA-15
• Device Catalogue Number: 101788
• Device Lot Number: LAP1619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/02/2025
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MA-03 (SERIAL NO.: (B)(6)); PLASMA SEPARATOR SULFLUX KP-05 (LOT NO.: FL5H5Q); TUBING NK-M3R(U) (LOT NO.: 210920)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male
• Date Report Sent to FDA: 07/01/2025