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	10/02/2025
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 kinked at 4.5cm from the distal tip; however, this would not have contributed to resistance at the hub.A video was provided showing the pusher of the fred being unable to advance fully into the hub of the microcatheter, which is consistent with the alleged product issue.Further investigation found incomplete flaring, ptfe damage/delamination, and an exposed coil protruding into the lumen at the hub transition, which would have caused the resistance described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the kink, but the damage is consistent with the device experiencing forces exceeding its yield strength.The physical evaluation of the device could not identify the conditions or circumstances that led to the exposed coil 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.The ptfe damage/delamination is consistent with attempting to advance another device into the microcatheter with incomplete flaring.
Event or Problem Description
It was initially reported that during the in-house simulated testing of stents at the manufacturing site, we had issues with headway 27 catheter.The pusher marker band area of the stent could not go through the catheter hub inner lumen.The inner lumen of the second catheter was verified using a pin gauge and confirmed the diameter is 0.026¿ (tight fit) with a 0.025¿ catheter moving freely.The proximal id needs to allow for a pin gauge of 0.0280-0.0283¿ to go through.When the device was received and analyzed, the microcatheter exhibited an exposed coil protruding into the lumen 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: 24228434
• Report Number: 2032493-2026-00048
• Device Sequence Number: 10187688
• Product Code: DQY
• UDI-Device Identifier: 00842429117507
• UDI-Public: (01)00842429117507(11)250522(17)280430(10)0001103251
• 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: 0001103251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• 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: 05/22/2025
• 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