MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY-17 XSUPPORT; PERCUTANEOUS CATHETER

Model Number	MC172150SX
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation found that an in-house guidewire could not advance through the returned headway microcatheter during functional testing, which is consistent with the alleged product issue.A dislodged lumen coil and damaged ptfe liner was found at the hub joint, which would have resulted in the resistance encountered.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the dislodged coil and damaged ptfe liner, but these conditions are consistent with a deviation in the manufacturing process.A capa has been initiated.The findings from the product investigation identified a manufacturing or potential manufacturing issue which has been escalated to quality systems management.A capa has been initiated.A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.
Event or Problem Description
It was reported that syncho standard 014 wouldn¿t go through the hub.Procedure completed as expected.This complaint was originally assessed as non-reportable.However, based on the product evaluation findings, a report is being conservatively based on exposed braid identified within the microcatheter lumen during evaluation.

• Brand Name: HEADWAY-17 XSUPPORT
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 22162574
• Report Number: 2032493-2025-90238
• Device Sequence Number: 8920999
• Product Code: DQY
• UDI-Device Identifier: 00810170013751
• UDI-Public: (01)00810170013751(11)240530(17)270430(10)0000610567
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083343
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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: MC172150SX
• Device Lot Number: 0000610567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• 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: 06/06/2025
• Initial Report FDA Received Date: 06/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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
• Patient Sex: Unknown