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
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 / 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
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.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 second microcatheter.The first microcatheter is referenced under mfr report# 2032493-2025-00158.
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.
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 a flattened section at 27cm from the strain relief; furthermore, an in-house stent could not advance past the site of the flattened section during the investigation, which is consistent with the alleged product issue.No damage or other anomaly was observed with the hub or distal tip of the microcatheter.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces exceeding the device's yield strength.This report addresses the second microcatheter.The first microcatheter is referenced under mfr report# 2032493-2025-00158.

• 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: 21441863
• Report Number: 2032493-2025-00159
• Device Sequence Number: 4683951
• 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