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

Model Number	MC172150JX-AL
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance's 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 ptfe damage/delamination and an exposed coil protruding into the lumen at the hub transition, which would have contributed to the reported resistance.The physical evaluation of the device could not identify the conditions or circumstances that led to the exposed 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.The ptfe damage/delamination is consistent with attempting to advance another device into the microcatheter with an exposed coil.
Event or Problem Description
It was initially reported that the microwire could not be inserted into the catheter hub.A new headway product was used instead.The patient was reported to be stable.When the device was received and analyzed, the microcatheter exhibited an exposed coil protruding into the lumen at the hub transition.

• 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: 24228538
• Report Number: 2032493-2026-00051
• Device Sequence Number: 10269740
• Product Code: DQY
• UDI-Device Identifier: 00842429117460
• UDI-Public: (01)00842429117460(11)240506(17)270430(10)0000591172
• 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): 01/30/2026

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: MC172150JX-AL
• Device Lot Number: 0000591172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• 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: 01/15/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 63 KG