MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY 21+; CATHETER PERCUTANEOUS

Model Number	MC212156S-AL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was reported available for return but has not yet been received.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
It was reported that the microcatheter was being used with a flow diverter stent in unspecified embolization procedure.Reportedly, there was resistance at the hub of the microcatheter that damaged 2 flow diverter stents that were attempted to be advanced in the microcatheter.The physician could not change the microcatheter as navigation was very difficult and finally managed to open the hub of the microcatheter by introducing the proximal end of a 0.14 guidewire.A new flow diverter stent was then advance and implanted and the procedure was successfully completed.Reportedly, the procedure time was extended by 30 minutes due to this problem.There was no report of injury to the patient.
Additional Manufacturer Narrative
Additional information: d10 (date device returned), h6, h11 (device evaluation conclusion).Investigation conclusion: the investigation found that an in-house stent experienced resistance when attempting to advance through the lumen of the returned headway microcatheter.The lumen of the microcatheter was found to have damaged/delaminated ptfe liner and the lumen coil exposed at the hub joint, which is consistent with the "defect at the hub" described in the reported event and would have resulted in the resistance encountered.However, the in-house stent system used was not damaged upon deployment from the headway during the investigation.The stent used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The catheter condition is consistent with a deviation in the manufacturing process and will be addressed per the quality system process.A search for non-conformances associated with this part/lot number combination did not reveal any other production-related issues relevant to the complaint that occurred during manufacturing of the device.

• Brand Name: HEADWAY 21+
• 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: 22485914
• Report Number: 2032493-2025-90313
• Device Sequence Number: 8184304
• Product Code: DQY
• UDI-Device Identifier: 00842429117484
• UDI-Public: (01)00842429117484(11)240925(17)270831(10)0000711209
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MC212156S-AL
• Device Lot Number: 0000711209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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: SIL FLOW DIVERTER STENT (X3) (BALT)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown