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

Model Number	MC272156S-AL
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cerebral aneurysm embolization procedure, the fred stent device initially proved resistant to microcatheter insertion (only the tip coil penetrated); so, the device was replaced with another, and the procedure was successfully completed.When the device was received for evaluation, the investigation findings found exposed lumen coil and protruding braid.
Additional Manufacturer Narrative
The investigation found that an in-house stent encountered resistance when attempting to advance into the lumen of the returned headway microcatheter during functional testing, which is consistent with the advancement issue described in the reported event.Further inspection of the hub found the lumen coil dislodged/exposed, and a protruding braid, 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/exposed lumen coil and the protruding braid, but these conditions are consistent with a deviation in the manufacturing process and are being addressed through the quality system process.A capa has been initiated.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.

• Brand Name: HEADWAY
• 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: 24523632
• Report Number: 2032493-2026-00150
• Device Sequence Number: 21263403
• Product Code: DQY
• UDI-Device Identifier: 00842429117507
• UDI-Public: 00842429117507
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K142449
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: MC272156S-AL
• Device Catalogue Number: MC272156S
• Device Lot Number: 0001070856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2026
• 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: 02/18/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRED STENT
• Patient Age: 48 YR
• Patient Sex: Female