MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY-DUO 16; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	MC162167S
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the headway duo microcatheter was used with a non-microvention liquid embolic system in a middle meningeal artery (mma) embolization procedure.The anterior and posterior divisions on the left mma embolization completed successfully.During embolization of the anterior division of the right mma, embolization liquid was noted on fluoroscopy to come out in the proximal mma.The procedure was then aborted.No report of injury to the patient, who woke up well.No report of future plans to treat the right mma.On the table, the liquid embolic was noted to exit the distal tip of the microcatheter, but when the distal tip of the microcatheter was occluded with finger pressure, there was no obvious embolic leak.Anatomy was unremarkable.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part and lot number combination did not reveal any production related issues relevant to the complaint that occurred during manufacturing of the device.The device was reported available for return for analysis, but has not yet been received and procedure images not provided.Therefore, the alleged product issue cannot be confirmed at this time.If the device or additional information is received, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d10 (date device returned to manufacturer).The device was returned to the manufacturer and its analysis was completed as given below.Investigation conclusion: the investigation found the sofia catheter returned flattened at the distal tip and the headway microcatheter lumen occluded with solidified onyx liquid embolic.Due to the occlusion of the headway lumen, this investigation was unable to test for or assess the device for the alleged leak and; therefore, this complaint is considered non-verifiable.No ruptures or other external damage were observed on the returned headway microcatheter.The physical evaluation could not identify the conditions or circumstances that led to the sofia damage, but the damage is consistent with the device experiencing forces over specification and would not have contributed to the reported complaint.

• Brand Name: HEADWAY-DUO 16
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 19026433
• Report Number: 2032493-2024-00264
• Device Sequence Number: 8548696
• Product Code: DQO
• UDI-Device Identifier: 00810170014413
• UDI-Public: (01)00810170014413(11)230607(17)260531(10)0000375227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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 Expiration Date: 05/31/2026
• Device Model Number: MC162167S
• Device Lot Number: 0000375227
• 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: 03/17/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• 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: ONYX LIQUID EMBOLIC (MEDTRONIC); SOFIA 5FR MICROCATHETER
• Patient Sex: Unknown