MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY; MICROCATHETER

Model Number	MC212156S-AL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's 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.The device was returned to the manufacturer for analysis and the investigation ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.This report addresses the first microcatheter.
Event or Problem Description
It was reported as per our inr the same devices have their distal end not midline, so the flow diverting stents cannot be inserted and deployed.Upon check by the interventional neuroradiologist, the central hub of the catheter was not midline so the stent cannot pass thru.Device is still not with the patient but delayed the procedure and placement of the stent due to doing the placement check, as it happened twice for the same product, and they needed to do the catheter placement again prior deployment.The need to exchange and reposition the additional microcatheters added approximately an additional 30 minutes to the procedure.No harm was done to the patient.The patient is fine and well.
Additional Manufacturer Narrative
Correction to section b1, b2, and h1 to serious injury for the delay in the procedure.Investigation conclusion: the investigation of the returned headway microcatheter found the implant of a non-microvention device detached in the hub, which is consistent with the advancement difficulty described in the reported event.However, an in-house stent was able to advance through the microcatheter hub and deploy from the distal tip without resistance during the investigation.Furthermore, the investigation did not find any damage or other anomaly with the hub or distal tip of the microcatheter that would have caused or contributed to the reported event.This report addresses the first microcatheter.The second microcatheter is referenced under mfr report# 2032493-2025-00159.
Event or Problem Description
Please see correction to section b1, b2, and h1 from malfunction to serious injury for the delay in the procedure.Please see section h11 for device investigation results.

• Brand Name: HEADWAY
• Common Device Name: MICROCATHETER
• 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: 21441851
• Report Number: 2032493-2025-00158
• Device Sequence Number: 4683529
• Product Code: DQY
• UDI-Device Identifier: 00842429117484
• UDI-Public: (01)00842429117484(11)240702(17)270630(10)0000642381
• 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): 04/03/2025

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: 0000642381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2025
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 02/22/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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: CERUS ENDOVASCULAR CONTOUR STENT 021.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown