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

Model Number	MC17215090X-AL
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned despite attempts made.Additional due diligence attempts are ongoing.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.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.
Event or Problem Description
It was reported during a neurosurgery, the microcatheter had a wire sticking out of the tip.The microcatheter was exchanged for a new one, and the case was completed.There was no patient injury or intervention reported.The patient is in good condition.The clinic provided the event date as april 2025.The exact date is unknown.
Event or Problem Description
See h11.
Additional Manufacturer Narrative
This report is being submitted to notify of the following additional information received: e1: the distributor provided the hospital clinic full name and address, and the information is updated in e1 section of the report.D10: the device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
The investigation of the returned headway microcatheter found the lumen coil dislodged/delaminated from a section of the catheter at 5mm from the distal tip.The lumen coil and ptfe liner was found to be emerging from the distal tip as described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the dislodged coil, but this damage is consistent with the device experiencing forces exceeding the device's tensile strength.
Event or Problem Description
See h11.

• 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: 22110118
• Report Number: 2032493-2025-90192
• Device Sequence Number: 7356466
• Product Code: DQY
• UDI-Device Identifier: 00842429117453
• UDI-Public: (01)00842429117453(11)240510(17)270430(10)0000595949
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101542
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2025

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: MC17215090X-AL
• Device Lot Number: 0000595949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 05/30/2025; 07/29/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/19/2025; 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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 Age: 66 YR
• Patient Sex: Female