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

Model Number	MC162167S-AL
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
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.The investigation of the returned headway microcatheter found the outer surface of the hub to be intact; however, the lumen was found to have not been fully flared at the hub joint, with an exposed braid and delaminated ptfe.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the lumen flaring, exposed braid, and delaminated ptfe liner issue, but these conditions are consistent with a deviation in the manufacturing process and will be addressed per the quality system process.A capa has been initiated.
Event or Problem Description
It was reported that the microcatheter hub was found to be damaged during preparation.When the device was received for evaluation, the lumen was found to have not been fully flared at the hub joint, with an exposed braid and delaminated ptfe.

• 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: 22080860
• Report Number: 2032493-2025-90184
• Device Sequence Number: 15796338
• Product Code: DQO
• UDI-Device Identifier: 00842429117415
• UDI-Public: 00842429117415
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K120917
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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: MC162167S-AL
• Device Lot Number: 0000776896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• 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: 05/15/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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