MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY-DUO 16; ACCESS DEVICES

Model Number MC162156S

Device Problem Break (1069)

Patient Problems Paralysis (1997); Paresis (1998); Ischemia Stroke (4418)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the reported 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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.Images have been received.Upon completion of the image review, investigation, we will submit a supplemental mdr report.The instructions for use (ifu) identifies catheter breakage as potential complications associated with use of the device.

Event Description

It was reported that a during embolization treatment of the ophthalmic with phil through a headway microcatheter, a small distal segment of the catheter broke when removing the catheter from the phil embolization sticking to the phil cast in the ophthalmic artery.The following day the patient woke up paretic.A ct revealed a portion of the microcatheter moved distally through the blood flow resulting in a tica infarction.The patient underwent a decompressive craniectomy.She is reported in the intensive care unit awake, conscious, oriented, with preserved language and hemiplegic on the right side.

Manufacturer Narrative

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.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were 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 and 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 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.Ifu review (additional information can be found in the ifu): warnings the microcatheter should only be used by physicians who are familiar with angiographic and interventional procedures.It is important to follow the instructions for use prior to using this product.The microcatheter is provided sterile and non-pyrogenic unless the unit package is opened or damaged.Do not use if the packaging is breached or damaged.The microcatheter is intended for single use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death.Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.After use, dispose device in accordance with hospital and/or local government policy.Inspect the microcatheter prior to use for any irregularities or damage and discard if any inconsistencies are observed.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.Shaping mandrel is not intended for use inside the body.Ensure shaping mandrel is removed from microcatheter prior to introduction into the rhv or other accessories.Precautions verify microcatheter compatibility when using other ancillary devices commonly used in intravascular procedures.Physician must be familiar with percutaneous, intravascular techniques and possible complications associated with the procedure.The microcatheter has a lubricious surface and should be hydrated prior to use.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.Verify that the diameter of any guidewire or accessory device that is used is compatible with the inner diameter of the microcatheter prior to use.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: prior to use, flush the microcatheter lumen thoroughly with heparinized saline to prime the microcatheter and provide smooth movement of the guidewire within the microcatheter.A rotating hemostatic valve (rhv) may be attached to the microcatheter hub and used to facilitate the flushing process.Carefully insert the distal section of the guidewire into the microcatheter hub (refer to the guidewire instructions for use).A guidewire insertion tool may be used to facilitate insertion of the guidewire distal tip through an rhv and into the microcatheter hub.Advance the guidewire until the distal tip is near the distal end of the microcatheter.Gently tighten the rhv to maintain position.Slip the torque device over the proximal end of the guidewire to the desired location (refer to guidewire or torque device instructions for use).Secure the torque device in place by tightening the rotating knob.The torque device may be repositioned by loosening and retightening the rotating knob.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.Loosen the guiding catheter rhv and introduce the microcatheter/guidewire into the guiding catheter using the introducer sheath.Carefully advance the microcatheter/guidewire to the guiding catheter distal tip.After the microcatheter/guidewire reaches the tip of the guiding catheter, remove the introducer from the microcatheter shaft by retracting the introducer from the rhv and peeling off the introducer.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.Procedure/medical information review: imaging review, p23-0398 49840, (b)(6) 2023: photo-2023-02-17-14-44-53 (003): ap and lateral non-subtracted head single shots, no contrast, 2/14/2023, 11h13.A guiding catheter is positioned at the posterior genu of the ica.A microcatheter has been navigated distally into the very distal aspect of the right ophthalmic artery; its course is very tortuous.Radiopaque liquid embolic material is seen in multiple branches distal to the microcatheter.I cannot determine if/how much reflux of the embolic material there is over the microcatheter.Curved lines with measurements have been drawn on the images close to the course of the microcatheter (29.6 and 30 mm), but i do not understand what they are trying to show.Photo-2023-02-17-14-44-53 (005): ap and lateral non-subtracted head right ica dsa, with contrast, 2/14/2023, 11h28.The guiding catheter has been removed or pulled back proximally.The microcatheter is seen in the ophthalmic artery; i think i can see a faint shadow of the microcatheter proximally in the ica, possibly down to the level of the petrous ica, but it is difficult to tell.There is no obvious thrombus.Photo-2023-02-17-14-44-53 (007): ap and lateral non-subtracted head single shots, no contrast, 2/14/2023, 11h28.The cast of embolic material is again seen.I cannot really see the microcatheter on these images, except for the distal metallic marker in the distal ica.On these images, it appears that there is substantial length of phil covering the distal microcatheter.Photo-2023-02-17-14-44-53 (009): ap and lateral non-subtracted head single shots, no contrast, 2/14/2023, 11h22.The cast of embolic material is again seen.I cannot really see the microcatheter on these images, except for the distal metallic marker in the distal ica.On these images, it appears that there is substantial length of phil covering the distal microcatheter.Photo-2023-02-17-14-44-53: same as image photo-2023-02-17-14-44-53 (003).Only images of the procedure day are provided.A ct was done the following day and showed migration of the microcatheter fragment; no images of that ct are provided.From the event description, the distal microcatheter was embedded in phil and, during attempts at its retrieval, it fractured proximally.The event does not describe how long of a segment remained in the patient or where the most proximal part of the fractured microcatheter ended up, although photo-2023-02-17-14-44-53 (007) shows substantial reflux, which would have made microcatheter retrieval more difficult.From the event description, it must have been in the ica, allowing it to migrate distally to the ica terminus in a delayed fashion.The event description does not describe an attempt to fixate/stabilize the microcatheter with a stent.The reported complaint is non-verifiable.No product(s) were returned for evaluation, but five ap and lateral non-subtracted images were provided.Per the image labeled photo-2023-02-17-14-44-53 (003), a guiding catheter is seen positioned at the posterior genu of the ica.A microcatheter has been navigated distally into the very distal aspect of the right ophthalmic artery; its course is very tortuous.Radiopaque liquid embolic material is seen in multiple branches distal to the microcatheter.Per the image labeled photo-2023-02-17-14-44-53 (007), the cast of embolic material is again seen.The microcatheter is not clearly visible on these images, except for the distal metallic marker in the distal ica.On these images, it appears that there is substantial length of phil covering the distal microcatheter.Per the image labeled photo-2023-02-17-14-44-53 (005), the guiding catheter has been removed or pulled back proximally.The microcatheter is seen in the ophthalmic artery with what appears to be a faint shadow of the microcatheter proximally in the ica, possibly down to the level of the petrous ica, but it is difficult to tell.There is no obvious thrombus.Only images of the procedure day were provided.Per the event description, a ct was done the following day and showed migration of the microcatheter fragment; however, no images of that ct was provided.From the event description, the distal microcatheter was embedded in phil and, during attempts at its retrieval, it fractured proximally.The event does not describe how long of a segment remained in the patient or where the most proximal part of the fractured microcatheter ended up, although photo-2023-02-17-14-44-53 (007) shows substantial reflux, which would have made microcatheter retrieval more difficult.From the event description, it must have been in the ica, allowing it to migrate distally to the ica terminus in a delayed fashion.The event description does not describe an attempt to fixate/stabilize the microcatheter with a stent.As the event description stated that the microcatheter migration caused a massive infarction, but the provided images did not show an apparent thrombus, the entire complaint cannot be confirmed and therefore, is considered non-verifiable.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: HEADWAY-DUO 16
• Type of Device: ACCESS DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16461764
• MDR Text Key: 310449773
• Report Number: 2032493-2023-00588
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: MC162156S
• Device Lot Number: 0000155879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PHIL
• Patient Outcome(s): Required Intervention