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	10/22/2025
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.Investigation conclusion: the investigation found the microcatheter returned with a stent detached in the hub, which is consistent with the condition described in the reported event.The stent was retrieved intact and loaded onto the returned pusher with the returned introducer for functional testing.The stent was unable to be advanced past the hub of the returned microcatheter, which is consistent with the reported resistance.However, the stent was able to fully advance through an in-house microcatheter without resistance.Further investigation of the returned microcatheter found ptfe damage and exposed braid protruding into the lumen at the hub transition, which would have caused the reported resistance.The physical evaluation of the device could not identify the conditions or circumstances that led to the exposed braid, 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 physical evaluation of the device could not identify the conditions or circumstances that led to the ptfe damage, but this condition is consistent with attempting to advance an ancillary device into the microcatheter with exposed braid.
Event or Problem Description
It was reported that during preparation for a cerebral aneurysm embolization procedure, during stent progression, resistance was observed in the device as it passed through the microcatheter.After reinsertion of the device into its introducer sheath, the stent spontaneously released itself from the microcatheter hub.The products were replaced, and the procedure was successfully completed.When the device was received and analyzed, the microcatheter exhibited an exposed braid protruding into the lumen at the hub transition.

• 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: 25059625
• Report Number: 2032493-2026-00294
• Device Sequence Number: 13118481
• Product Code: DQY
• UDI-Device Identifier: 00842429117507
• UDI-Public: (01)00842429117507(11)250428(17)280331(10)0001069832
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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 Lot Number: 0001069832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• 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: 04/24/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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