MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY ADVANCED; CATHETER, PERCUTANEOUS

Model Number	MC17215090X
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As initially reported, the guidewire was not advanced in the headway 17 microcatheter.The procedure was complete with another product.The patient was reported to be stable.When the device was received and analyzed, the catheter exhibited exposed coil in the lumen.
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 lumen of the microcatheter was found to have delaminated ptfe liner with the lumen coil exposed, 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 ptfe delamination and exposed lumen coil, but this condition is consistent with a deviation in the manufacturing process and will be addressed per the quality system process.A capa has been initiated.

• Brand Name: HEADWAY 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 ; 7142478000
• MDR Report Key: 22467986
• Report Number: 2032493-2025-90311
• Device Sequence Number: 19892333
• Product Code: DQY
• UDI-Device Identifier: 00810170015489
• UDI-Public: (01)00810170015489(11)230808(17)260731(10)0000403660
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K101542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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 Expiration Date: 07/31/2026
• Device Model Number: MC17215090X
• Device Lot Number: 0000403660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2025
• 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: 06/16/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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