MAUDE Adverse Event Report: LEONI FIBER OPTICS, INC. TYPENEX MEDICAL; LASER FIBER ASSY-REUSABLE-3M LOH-HCS-.37NA 600-HARD PLASTIC CLAD-BLUE TEFZEL

Model Number	NV0635
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device malfunction reported to typenex medical who in turn notified leoni fiber optics, inc.Contact has been made with the doctor by typenex.Leoni fiber optics, inc has initiated an internal review.Currently waiting for more information.
Event or Problem Description
Evla procedure in the left saphenous vein.This was the first use of this fiber.15cm of the vein were ablated prior to the fiber fracture.Fiber remnants remain in the patient's leg.They are seeing vascular surgery to address.

• Brand Name: TYPENEX MEDICAL
• Common Device Name: LASER FIBER ASSY-REUSABLE-3M LOH-HCS-.37NA 600-HARD PLASTIC CLAD-BLUE TEFZEL
• Manufacturer (Section D): LEONI FIBER OPTICS, INC.; 209 bulifants blvd.; williamsburg VA 23188
• Manufacturer (Section G): LEONI FIBER OPTICS, INC.; 209 bulifants blvd.; williamsburg VA 23188
• Manufacturer Contact: laura cole ; 209 bulifants blvd.; williamsburg, VA 23188 ; 7572584808
• MDR Report Key: 16206361
• Report Number: 3007336385-2023-00001
• Device Sequence Number: 4880989
• Product Code: GEX
• UDI-Device Identifier: 00816901020470
• UDI-Public: 00816901020470
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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 Expiration Date: 02/19/2024
• Device Model Number: NV0635
• Device Catalogue Number: 097512
• Device Lot Number: J50524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown