MAUDE Adverse Event Report: MICROVENTION INC HEADWAY DUO MICROCATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	MC162156S-AL
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: they were not able to load the traxcess into the catheter.Information received notes it is a bit unclear if it was stuck in the hub or proximal part of the catheter.The procedure was completed as another duo catheter was used without problems.The same traxcess was used successfully with the new duo catheter.There was no patient impact, injury and no medical or surgical intervention performed.Patient status is "good".When the device was received for evaluation, the investigation findings found that the lumen coil was damaged and exposed.
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 that an in-house guidewire was unable to advance through the returned microcatheter, which is consistent with the alleged product issue.Further investigation found the ptfe liner damaged/delaminated with exposed coil at the hub join, which is consistent with the resistance encountered during the investigation.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the exposed coil and damaged ptfe liner, 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.

• Brand Name: HEADWAY DUO MICROCATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MICROVENTION INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 22235774
• Report Number: 2032493-2025-90261
• Device Sequence Number: 20877044
• Product Code: DQO
• UDI-Device Identifier: 00842429117408
• UDI-Public: (01)00842429117408(11)241218(17)271130(10)0000829999
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K120917
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: MC162156S-AL
• Device Lot Number: 0000829999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• 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: 06/04/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRAXCESS UNKNOWN DETAILS
• Patient Sex: Unknown