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

Model Number	MC212156S-AL
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation found that an in-house guidewire could not be advanced through the returned microcatheter, which is consistent with the alleged product issue.Further investigation found incomplete flaring at the hub transition and an exposed lumen coil protruding into the lumen, which would have caused the resistance encountered during the investigation.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.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
As reported: synchro 14 wire would not fit through the headway 21.The headway 21 was flushed and the synchro wire was lubricated to insure proper fit.There was no patient injury.The patient outcome was reported as good.The device is available for evaluation.The product investigation found exposed lumen coil protruding into the lumen.

• 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: 23548051
• Report Number: 2032493-2025-90650
• Device Sequence Number: 15882519
• Product Code: DQY
• UDI-Device Identifier: 00842429117484
• UDI-Public: 00842429117484
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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: MC212156S-AL
• Device Catalogue Number: MC212156S
• Device Lot Number: 0000638683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• 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: 10/21/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SYNCHRO 14 GUIDEWIRE.
• Patient Sex: Unknown