MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY 17 ADVANCED; CATHETER, PERCUTANEOUS

Model Number	MC17215045X-AL
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, impossible to introduce the web in 3 microcatheters: (x2) via 17 and (x1) headway 17, lot: 000993008.The physician finally decided to use an artisse.There was no report of injury.No consequence for the patient.When the device, headway 17 microcatheter was received for evaluation, the investigation findings revealed an exposed lumen coil protruding into the catheter lumen.Therefore, a report is being submitted.
Additional Manufacturer Narrative
The investigation of the returned web system found the proximal connector kinked and the web wires twisted at the proximal side; furthermore, the device could not be advanced into an in-house via or the returned via microcatheters during functional testing, which is consistent with the alleged product issue.The physical evaluation of the web device could not identify the conditions or circumstances that led to the connector damage and the twisted wires, but the damage is consistent with the device experiencing forces exceeding the pusher and implant's yield strength.The returned via microcatheter was found to have flattened areas at the distal end but would not have caused or contributed to the reported web insertion.However, the returned headway microcatheter was found to not be fully flared at the hub joint with an exposed braid protruding into the lumen and delaminated ptfe lining, which would have caused or contributed to the web insertion issue.The physical evaluation of the headway microcatheter could not identify the exact conditions or circumstances that led to the exposed braid, delaminated ptfe lining, and lumen flaring issue, but these conditions are consistent with a deviation in the manufacturing process.A capa has been initiated.

• Brand Name: HEADWAY 17 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: 24748663
• Report Number: 2032493-2026-00209
• Device Sequence Number: 21009496
• Product Code: DQY
• UDI-Device Identifier: 00842429117446
• UDI-Public: (01)00842429117446
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083343
• 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): 03/31/2026

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: MC17215045X-AL
• Device Lot Number: 0000993008
• 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: 03/17/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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: (X2) VIA 17
• Patient Sex: Unknown