MAUDE Adverse Event Report: LIMFLOW INC. LIMFLOW VECTOR; VALVULOTOME

Model Number	VT-US-23
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.Upon completion of the investigation a follow-up report will be submitted.Manufacturer reference: (b)(4).
Event or Problem Description
On (b)(6) 2025, during a limflow transcatheter arterialization of deep veins (tadv) procedure the medical team had difficulty delivering the vector to the starting point.The nose cone of the vector device broke off on the wire.The physician was able to push the nose cone out with a balloon through the distal venous access.There was no injury, and the nose cone was successfully removed.A second vector device was used and the procedure was completed without further issues.
Additional Manufacturer Narrative
The vector device was returned to the manufacturer and evaluated.The catheter and the tip were returned.No manufacturing deficiencies were identified when the catheter and tip were investigated.Adequate adhesive residue was observed in the correct location on the tip.The root cause was not established during the investigation; however, the field failure was most likely due to the device navigating a challenging anatomy.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.Additionally, there have been no similar complaint events for this lot number.Manufacturer reference: (b)(4).

• Brand Name: LIMFLOW VECTOR
• Common Device Name: VALVULOTOME
• Manufacturer (Section D): LIMFLOW INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer (Section G): CONFLUENT MEDICAL TECHNOLOGIES; coyol free zone; building 28; alajuela, ; CS
• Manufacturer Contact: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 23287785
• Report Number: 3023527320-2025-00004
• Device Sequence Number: 12152553
• Product Code: MGZ
• UDI-Device Identifier: 00850041730134
• UDI-Public: 00850041730134
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: VT-US-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male