MAUDE Adverse Event Report: MicroVention, Inc. Headway 27 Microcatheter; Catheter, Percutaneous

Model Number	MC272156S
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: stent would not advance through headway 27 catheter.Stent deployed in catheter hub.A new headway 27 and stent were required.Type of surgery being performed and treatment site: aneurysm embolization with flow diverting stent.When the device was received for evaluation, the investigation findings found an exposed coil/braid protruding into the lumen at the hub transition.
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 found the stent returned partially deployed from the introducer and deformed with damaged and misaligned end loops.The pusher was returned with the distal coil stretched at the proximal end.The stent was loaded onto the returned pusher with the returned introducer and advanced into an in-house microcatheter without resistance; however, the stent could not be resheathed due to the damaged proximal flares, which is consistent with the reported detachment in the hub.The physical evaluation of the stent could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces exceeding the implant and pusher's yield strengths.The microcatheter used in the procedure was found to have ptfe damage and exposed coil/braid protruding into the lumen at the hub transition, which would have caused or contributed to the reported event.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the ptfe damage and exposed coil and braid, 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.

• Brand Name: Headway 27 Microcatheter
• 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 ; +1(714)247-8000
• MDR Report Key: 50727673
• Report Number: 2032493-2026-08224
• Device Sequence Number: 16100097
• Product Code: DQY
• UDI-Device Identifier: 00842429117507
• UDI-Public: 00842429117507
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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
• Device Lot Number: 0001107996
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2026
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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
• Patient Sex: Unknown