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

Model Number	MC162156S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Upon removal of the catheter from the intended embolization site in the patient's middle meningeal artery, onyx leaked out of the catheter causing the catheter to stretch and snap off.Piece of the microcatheter was retained inside the patient's artery.

• Brand Name: HEADWAY DUO
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICROVENTION INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 12091809
• Report Number: 12091809
• Device Sequence Number: 17208281
• Product Code: DQY
• UDI-Device Identifier: 00810170014345
• UDI-Public: (01)00810170014345
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/23/2021
• Report Date (Section F): 06/23/2021

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
• Device Catalogue Number: MC162156S
• Device Lot Number: 20121652J
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 51
• Date Report Sent to FDA: 06/23/2021