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	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the attempt to introduce the stent into the microcatheter, it was verified that the delivery system advanced, but the stent got stuck at the entrance of the microcatheter, damaging the mesh and obstructing the microcatheter.The devices were replaced, and the procedure was completed successfully.There was no patient injury.The patient outcome was reported as great.When the device was received and analyzed, it was found that the catheter shaft exhibited incomplete flaring with exposed braid at the hub transition.
Additional Manufacturer Narrative
The investigation found the stent returned detached in the hub of the microcatheter with a kinked proximal flare, which is consistent with the alleged product issue.Further inspection of the microcatheter found the lumen to not be fully flared at the hub joint with the lumen coil exposed, which would have resulted in the advancement issue encountered during the reported event.The exposed braid was observed to be protruding into the lumen.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the exposed braid and lumen flaring issue, 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.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: 24069403
• Report Number: 2032493-2026-00017
• Device Sequence Number: 9113316
• Product Code: DQY
• UDI-Device Identifier: 00842429117507
• UDI-Public: (01)00842429117507(11)250426(17)280331(10)0001068691
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101542
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

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: 0001068691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• 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: 12/19/2025
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2025
• 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.
• Patient Sex: Female