MAUDE Adverse Event Report: VESALIO, INC. PVASC 6.0X44 MM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	VP-6044-F3RR
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a proactive outreach to the physician, (b)(6) was notified that during surgery on wednesday ((b)(6) 2025), the pvasc 6.0x44 expandable tip detached from the pusher wire and the expandable tip could not be removed.The pusher wire was removed and discarded.Upon follow-up, the following information was provided by the physician: - the procedure involved a chronic iliac occlusion.- a 2.7 headhunter was used though a bolt 6 to deploy the pvasc device.- once engaged with the chronic clot, an attempt was made to withdraw the pvasc device into the penumbra bolt 6 catheter by a non-physician while the physician was not supervising them.- the product detached and the physician tacked it with a stent.The physician mentioned that he planned to place a stent in the vessel anyway.- the pvasc wire was disposed.

• Brand Name: PVASC 6.0X44 MM
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): VESALIO, INC.; 2305 historic decatur rd.; suite 100; san diego CA 92106 6071
• MDR Report Key: 21963422
• Report Number: 3014498720-2025-00001
• Device Sequence Number: 8415200
• Product Code: QEW
• UDI-Device Identifier: 00851279008514
• UDI-Public: 851279008514
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

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: VP-6044-F3RR
• Device Catalogue Number: VP-6044-F3RR
• Device Lot Number: 101524B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown