MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY-17 ADVANCED; ACCESS DEVICES

Model Number MV-MF175A

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

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, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.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.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of 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): please refer to the japanese ifu for precautions, warnings, and further information.The following is taken from the english version: 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 300 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 300 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.The device was discarded at the user facility and not returned to the manufacturer for evaluation.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.The event as described could not be confirmed.If additional information is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.

Event Description

It was reported that during treatment to embolize an ic aneurysm using a double catheter technique, resistance was encountered as the embolization coil was advanced in the microcatheter.The coil was removed from the patient, rinsed and placed in a tray.A fibrous object was observed in the tray.The coil was not used and was replaced with another coil.They microcatheter was discarded.The procedure was completed successfully.No patient harm or injury was reported.

• Brand Name: HEADWAY-17 ADVANCED
• Type of Device: ACCESS DEVICES
• 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: 17322090
• MDR Text Key: 319768991
• Report Number: 2032493-2023-00849
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350609113
• UDI-Public: (01)04987350609113(11)210430(17)240331(10)210430541
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101542
• 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
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: MV-MF175A
• Device Lot Number: 210430541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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: HYDROSOFT 3D
• Patient Outcome(s): Other