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

Model Number	MC17215090X
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation found the returned microcatheter to have flattened areas at the distal end, the hub joint not fully flared, and an exposed braid protruding into the lumen, which would have caused or contributed to the guidewire advancement issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the flattened sections, but the damage is consistent with the device experiencing forces exceeding its yield strength.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the lumen flaring issue and exposed 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.The returned guidewire was found damaged at 3cm from the distal tip, which is consistent with being advanced into the microcatheter with the exposed braid.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 that the guidewire could not be properly advanced into the catheter.Both devices were retrieved and the investigation was completed successfully.There was no patient injury.The patient outcome was reported to be stable.When the device was received and analyzed, it was found that the catheter shaft exhibited incomplete flaring with exposed braid at the hub transition.

• Brand Name: HEADWAY ADVANCED
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 01923
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 01923 ; 7142478000
• MDR Report Key: 24477362
• Report Number: 2032493-2026-00139
• Device Sequence Number: 9643597
• Product Code: DQY
• UDI-Device Identifier: 00810170015489
• UDI-Public: (01)00810170015489(11)221214(17)251130(10)0000298678
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/27/2026

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 Expiration Date: 11/30/2025
• Device Model Number: MC17215090X
• Device Lot Number: 0000298678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• 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: 02/02/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2022
• 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: TRAXCESS GUIDEWIRE.
• Patient Sex: Unknown