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	10/07/2025
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 returned microcatheter to exhibit incomplete flaring with an exposed braid at the hub transition, which would have caused the resistance described in the reported event.The exposed braid was found to be protruding into the lumen.The physical evaluation of the device could not identify the conditions or circumstances that led to the exposed braid and 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.
Event or Problem Description
It was initially reported that the luer sample was unused and was removed from the packaging.The luer hub was trimmed to get a closer look at the catheter inner diameter.We couldn¿t insert a pin gage of 0.026¿ minus; the pin gauge was measured with a laser micrometer, and the diameter was around 0.02592.¿ the diameter in this case is below the final inspection acceptable diameter.When the device was received and analyzed, the microcatheter exhibited an exposed braid 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: 24228509
• Report Number: 2032493-2026-00050
• Device Sequence Number: 21389778
• Product Code: DQY
• UDI-Device Identifier: 00842429117507
• UDI-Public: (01)00842429117507(11)250526(17)280430(10)0001106464
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

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: Other
• Device Model Number: MC272156S-AL
• Device Lot Number: 0001106464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• 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: 01/15/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2025
• 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
• Patient Sex: Unknown