MAUDE Adverse Event Report: MICROVENTION INC. HEADWAY-DUO 16; CATHETER PERCUTANEOUS

Model Number	MC162167S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
See h11.
Additional Manufacturer Narrative
Procedure/medical information review: medical operative report review.A detailed review of the medical operative report dated (b)(6) 2025, was performed on (b)(6) 2025.As reported through the clinical study, coil embolization of the left mca aneurysm was performed utilizing a headway duo-16 device.Index procedure date was (b)(6) 2025.During the performance of the procedure, the headway duo-16 device was reported as starting to herniate into the parent vessel during the attempted insertion of a hydrosoft 2 mmx 4cm coil.Operative physician attempted to retract the coil while advancing the microcatheter, but the microcatheter herniated into the m2 branch.Initial coils remained within the aneurysm without change in position.Operative physician indicates that an attempted second coil placement was performed but could not place this coil as the microcatheter herniated out of the aneurysm.Anterior and posterior lateral cranial runs were obtained which indicated stable coiling and cervical runs showed no dissection or injury.Based on a review of the data and in my professional opinion the microcatheter herniation into the m2 branch and no dissection or injury was reported.The relationship of this event to the headway duo-16 microcatheter cannot be ruled out.No device malfunction was reported and/or no device malfunction was reported as the cause of the event.Investigation findings: a review of the medical operative report was performed.Based on a review of the data, the microcatheter herniation into the m2 branch and no dissection or injury was reported.The relationship of this event to the headway duo-16 microcatheter cannot be ruled out; however, no device malfunction was reported as the cause of the event.Without the return and physical evaluation of the device, the investigation cannot further examine if a condition existed that would have contributed to the reported event.Batch review: 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.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Based on a review of the device¿s risk documentation, the reported event did not indicate there were the presence of any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform an analysis of the device, this investigation cannot identify with certainty any potential root causes.Ifu review (additional information can be found in the ifu): warnings the microcatheter should be advanced or manipulated under fluoroscopic guidance.Do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined.Infusion pressure should not exceed 700 psi to avoid potential rupture of the microcatheter.Precautions exercise care in handling the microcatheter to reduce the chance of accidental damage.With the exception of dimethyl sulfoxide (dmso), use of organic solvents may damage the microcatheter and/or coating on the surface.Potential complications include,but are not limited to: vessel or aneurysm perforation, vasospasm, hematoma at the site of entry, embolism, ischemia, intracerebral/intracranial hemorrhage, pseudoaneurysm, seizure, stroke, infection, vessel dissection, thrombus formation, and death.To reduce the risk of damage or separation of the device, avoid repeated bending at the same point of the microcatheter.Take precaution when manipulating the microcatheter in tortuous vasculature to avoid damage to the microcatheter.Avoid advancing or withdrawal against resistance until the cause of resistance is determined.Directions for use carefully insert the distal section of the guidewire into the microcatheter hub (refer to the guidewire instructions for use).Advance the guidewire until the distal tip is near the distal end of the microcatheter.Slip the torque device over the proximal end of the guidewire to the desired location (refer to guidewire or torque device instructions for use).A guiding catheter is placed into the appropriate vessel and the microcatheter/guidewire assembly is then advanced through the guiding catheter to the target vessel or vascular lesion.Set up a continuous flush of heparinized saline by connecting rhvs with pressurized flush solution lines to the hub of the guiding catheter and microcatheter.Carefully advance the microcatheter/guidewire to the guiding catheter distal tip.During navigation in the vasculature, advance the guidewire a short distance, then advance the microcatheter over the guidewire and repeat until the desired site is reached.The proximal portion of the microcatheter does not have the hydrophilic surface and may encounter resistance when this section is advanced through the rhv.Once the desired location has been reached, the guidewire is removed from the microcatheter.The diagnostic or therapeutic agent(s) are then prepared for delivery through the microcatheter.Warning: do not exceed the maximum recommended infusion pressure of 700 psi.Between uses, rinse the microcatheter in a basin of heparinized saline and wipe it gently with sterile, wet gauze and place in a basin of heparinized saline or a flushed dispenser tube to keep the hydrophilic surface wet until use.
Additional Manufacturer Narrative
The device is not being returned for investigation by the manufacturer.However, an operative report was provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.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.
Event or Problem Description
As reported through the veeva vault clinical study management system, event#1 device deficiency description: device herniated into parent vessel preventing deployment.Additional information was received that stated as the operator was coiling the target aneurysm with a coil, and it was initially looping in the ta, but as the coils were fully deployed, they began to herniate into the parent vessel.They repositioned the catheter and coil.The coil had deployed with good coil compaction.They proceeded to attempt a second coil deployment.Again, they started to loop the coil but after the initial loop the catheter began to herniate into the parent vessel.They attempted to retract the coil while advancing the microcatheter; however, the catheter continued to herniate out now into the m2 branch.The 2nd coil was retrieved, and the procedure concluded.The additional treatment will be scheduled once the aneurysm stabilizes.The patient tolerated the procedure well.The vital signs were stable.

• Brand Name: HEADWAY-DUO 16
• 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: 21866667
• Report Number: 2032493-2025-90086
• Device Sequence Number: 4684375
• Product Code: DQY
• UDI-Device Identifier: 00810170014413
• UDI-Public: (01)00810170014413(11)221018(17)250930(10)0000273917
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: MC162167S
• Device Lot Number: 0000273917
• Was Device Available for Evaluation?: No
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2022
• 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: 5 FR SOFIA ACCESS CATHETER.; HYDROSOFT 3D COIL.; HYDROSOFT COIL.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female