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

Model Number	MC162156S
Medical Device Problem Codes	Material Disintegration (1177); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information in sections b3 (event date) and d4 (device model and lot number) was not provided and is unknown.Additional information was requested but has not been received.Investigation findings: items returned: n/a visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation; however, the condition of the reported headway duo can be observed in the 5 minute video embedded in the attached article at approximately 2 minute and 25 seconds into the video.The headway duo can be seen stretched and flattened proximal to the break location, with the catheter lumen wire stretched and entangled distal to the break location.Investigation findings: 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.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.Batch review: a search for non-conformances associated with this part/lot number combination could not be performed as this information was not available at the time this investigation was performed.Complaint system review: a search of the complaint handling system could not be performed to determine if other similar complaints exist for this batch number, because the batch number was not provided for the product on this complaint file.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.Investigation conclusions: a journal article was provided for review.This report is about a publication that describes entrapment of a headway duo microcatheter in onyx in the mma during an embolization procedure for a chronic left-sided sdh.There is a 5-minute video link included in the provided pdf of the publication; it shows snippets of the entire procedure, from radial approach catheter insertion, catheterization of the left cca, eca, and mma, embolization of onyx, fracture of the duo microcatheter, and retrieval of the fragment with a stent retriever.This type of complication is known to occur when a relatively long segment of microcatheter is embedded in onyx (or nbca) during embolization procedures.The retained microcatheter can be left in place, or removed by a variety of methods, such as a stent retriever, as was the case here.
Event or Problem Description
As reported through the technical video, journal article titled, ¿management of a fractured microcatheter during middle meningeal artery embolization¿, here we describe the management of a retained and fractured microcatheter following liquid embolic for middle meningeal artery embolization (mmae).A patient with chronic recurrent subdural hematomas underwent bilateral mmae with a competitor liquid embolic material.The headway duo microcatheter was placed in a small distal frontal branch of the middle meningeal artery to aid in reflux into the posterior middle meningeal artery branches.Following successful mmae, the microcatheter became trapped within the liquid embolic material cast and, on attempted removal, the microcatheter fractured, resulting in a retained fragment extending from the middle meningeal artery cast to the guide catheter in the common carotid artery.To retrieve the fractured microcatheter, a stent retriever was deployed and re-sheathed multiple times until the retained microcatheter became visibly entangled with the stent retriever.Next, the stent retriever was pulled back into the guide catheter and continuous aspiration was performed through the guide catheter, and the fragmented microcatheter was successfully removed in entirety.Final angiography demonstrated no further catheter fragments, vessel damage, extravasation, flow limitation, or thromboembolic complications.This case demonstrates the successful use of a stent retriever and aspiration to retrieve a retained and fractured microcatheter following liquid embolic mmae.
Additional Manufacturer Narrative
This supplemental report is submitted to provide additional information that has been received relating to patient age, gender and race and is provided in sections a2, a3a and a6.
Additional Manufacturer Narrative
Additional information was received from the physician.Patient outcome after procedure completed described as, "patient did not suffer any clinical complications and made a full recovery immediately post operative and long term without complication." date of event and device lot number were provided.The device was not returned.Per provided device lot number: 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.

• 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: 20646693
• Report Number: 2032493-2024-00818
• Device Sequence Number: 7367396
• Product Code: DQO
• UDI-Device Identifier: 00810170014345
• UDI-Public: (01)00810170014345(11)240212(17)270131(10)0000516906
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2024

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: MC162156S
• Device Lot Number: 0000516906
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 12/03/2024; 12/03/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/06/2024; 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Race: White