MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	MC162156S-AL
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Investigation conclusion: the investigation found that an in-house guidewire could not be advanced into the returned microcatheter, which is consistent with the alleged product issue.Further investigation found incomplete flaring of the proximal microcatheter shaft with exposed braid and damaged ptfe lining, which would have caused the resistance experienced during functional testing.The physical evaluation of the device could not identify the conditions or circumstances that led to the flaring issue and exposed braid, but these conditions are consistent with a deviation in the manufacturing process.A capa has been initiated.The ptfe damage is consistent with attempting to insert another device into the partially flared lumen.
Event or Problem Description
As initially reported, the wire would not go through the hub of the microcatheter, and team had to backload wire.When the device was received and analyzed, proximal microcatheter shaft exhibited incomplete flaring with exposed braid.

• Brand Name: HEADWAY
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 22846500
• Report Number: 2032493-2025-90422
• Device Sequence Number: 19955306
• Product Code: DQO
• UDI-Device Identifier: 00842429117408
• UDI-Public: (01)00842429117408(11)240904(17)270831(10)0000694660
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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: MC162156S-AL
• Device Lot Number: 0000694660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• 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: 07/29/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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: Male