MAUDE Adverse Event Report: VESALIO, INC. PVASC 6.0 MM X 44 MM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION, PRODUCT CODE: QEW

Model Number	VP-6044-F3RR
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During thrombectomy of lower leg (tibial artery) the pvasc detached from the delivery wire while trying to remove device from body.Large piece of tissue (not clot) was trapped between the tip of the penumbra bolt 7 and the pvasc device.This large chunk got caught in the pvasc and since it was solid and much larger than the bolt 7 tip, the friction an force caused the pvasc to detach.

• Brand Name: PVASC 6.0 MM X 44 MM
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION, PRODUCT CODE: QEW
• Manufacturer (Section D): VESALIO, INC.; 2305 historic decatur rd.; suite 100; san diego CA 92106 6071
• Manufacturer Contact: hung nguyen ; 105 n. pointe drive; lake forest, CA 92630 ; 9494918327
• MDR Report Key: 25223015
• Report Number: 3014498720-2026-00002
• Device Sequence Number: 21284620
• Product Code: QEW
• UDI-Device Identifier: 00851279008514
• UDI-Public: 851279008514
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/23/2026

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: VP-6044-F3RR
• Device Catalogue Number: VP-6044-F3RR
• Device Lot Number: 112125D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2026
• Initial Report FDA Received Date: 05/19/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown