MAUDE Adverse Event Report: MicroVention, Inc. Headway 17 Advanced; Catheter, Percutaneous

Model Number	MC172150S
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction

• Brand Name: Headway 17 Advanced
• Common Device Name: Catheter, Percutaneous
• Manufacturer (Section D): MicroVention, Inc.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; +1(714)247-8000
• MDR Report Key: 50455682
• Report Number: 2032493-2026-08180
• Device Sequence Number: 21412478
• Product Code: DQY
• UDI-Device Identifier: 00810170013744
• UDI-Public: 00810170013744
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: MC172150S
• Device Lot Number: 0000906376
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/12/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 147 LB