MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA-6F; PERCUTANEOUS CATHETER

Model Number DA6131ST-ASP-US-OD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Intracranial Hemorrhage (1891)

Event Date 08/15/2023

Event Type  Injury  

Event Description

It was reported for a patient enrolled in the sofast study that a patient developed a cerebral hemorrhage on (b)(6) 2023 due to their initial thrombectomy.Antiplatelets were held, and it resolved without sequelae on (b)(6) 2023.Action required - ae: intervention.Intervention - held antiplatelets.Outcome - ae: resolved without sequelae.Date of resolution: (b)(6) 2023.Related to: initial thrombectomy.Event outcome: resolved.Relationship to sofia device: possibly.Relationship to mechanical thrombectomy procedure: possibly.Relationship to study disease: definitely.Relationship to concurrent condition/treatment: possibly.Characterize hemorrhagic transformation: ph2: hematoma in > 30% of infarcted area with substantial space occupying effect.

Manufacturer Narrative

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, 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: based on a review of the last 2 years of complaint data, and at the time of this investigation, no systemic issues have been identified for this batch number that would have caused or contributed to the reported event.Ifu review (additional information can be found in the ifu, the following is taken from the 27 language version): potential complications: potential complications include but are not limited to: vessel or aneurysm perforation, vasospasm, hematoma at the site of entry, embolism, ischemia, intracerebral/intracranial hemorrhage, pseudo aneurysm, seizure, stroke, infection, vessel dissection, thrombus formation, and death.Precautions: exercise care in handling the sofia¿ catheter to reduce the chance of accidental damage.Use caution when manipulating the sofia¿ catheter in tortuous vasculature to avoid damage.Avoid advancing or withdrawal against resistance until the cause of resistance is determined.Presence of calcifications, irregularities, or other devices may damage the sofia¿ catheter and potentially affect its insertion or removal.Maintain perfusion of heparinized saline for inner lumen of the sofia¿ catheter to prevent thrombus formation.If removed from the patient, the hydrophilic coating on the sofia¿ catheter should be hydrated with heparinized saline.Do not allow the coating to dry.Delivery of the sofia¿ catheter: 6.Go to step 7 or 8, depending on the situation described below and choose appropriate devices for navigation of the sofia¿ catheter.7.Navigation through the vasculature, except for the intracranial vasculature c.Using the introducer sheath provided in the package, carefully insert the sofia¿ catheter and the guidewire through a hemostatic valve of the femoral sheath.E.Under fluoroscopic guidance, advance or withdraw the sofia¿ catheter over the guidewire until desired position is attained or before the intracranial position is achieved.Select vessels by slowly torquing the sofia¿ catheter if necessary.Warning: do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined.Warning: torquing the sofia¿ catheter excessively while kinked may damage the device resulting in separation of the device.Withdraw the entire device (the device, microcatheter, and guidewire) if the device is severely kinked.Warning: do not exceed 2070 kpa (300 psi) maximum recommended infusion pressure.Excess pressure may damage the device or injure the patient.Carefully monitor placement of the distal tip when using a power injector to infuse.F.Go to step 8 for navigation through the intracranial vasculatures.Otherwise proceed to step 9.8.Navigation through the intracranial vasculature.C.Under fluoroscopic guidance, advance or withdraw the sofia¿ catheter over the microcatheter and the guidewire until desired position is attained.Select vessels by slowly torquing the sofia¿ catheter if necessary.Warning: do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined.Warning: torquing the sofia¿ catheter excessively while kinked may damage the device resulting in separation of the device.Withdraw the entire device (the device, microcatheter, and guidewire) if the device is severely kinked.Warning: do not exceed 2070 kpa (300 psi) maximum recommended infusion pressure.Excess pressure may damage the device or injure the patient.Carefully monitor placement of the distal tip when using a power injector to infuse.Aspiration through the sofia¿ catheter with syringe.7.Make sure that the syringe aspirates blood, emboli, or thrombi through the system.Close the stopcock if the syringe does not aspirate any blood, emboli, or thrombi, or slow aspiration is observed.Carefully investigate the cause of the restriction and reposition the distal tip if necessary.If blood, emboli, or thrombi is stuck in the sofia¿ catheter remove the entire device (the device, microcatheter, and guidewire) and clear the inner lumen.If restriction still remains and the distal tip of the sofia¿ catheter has been repositioned correctly, close the stopcock, re-attach the syringe, and resume aspiration.Maintain aspiration to make sure the emboli or thrombi remains fully engaged with the distal tip of the sofia¿ catheter.With the emboli or thrombi fully engaged pull back the sofia¿ catheter out of the patient body.Warning: excessive aspiration with the distal tip of the sofia¿ catheter covered by the vessel wall may cause vessel injury.8.After aspiration is completed, remove the sofia¿ catheter from the patient body.If re-access to the vasculatures with the same device is desired, flush and clean the inner lumen of the device by infusion.Inspect the device for any damage.Follow steps 6 through 9 in the delivery of the sofia¿ catheter section for navigation.Warning: do not use the device if any damages or irregularities are observed.Aspiration through the sofia¿ catheter with pump.3.Attach aspiration tubing to the aspiration pump and turn on the pump (refer to the directions for use of the aspiration tubing and aspiration pump manual).Confirm that the aspiration gauge reads -20 inhg.Ensure the stopcock on the aspiration tubing is in the closed position.7.To begin aspiration, turn the aspiration tubing stopcock to the open position and check to see if blood, thrombus, or embolus are aspirated through the system.8.If after 10 seconds blood is still observed flowing through the system, stop aspiration.To stop aspiration, turn aspiration tubing stopcock to the closed position.Carefully reposition the distal tip of the sofia¿ catheter to engage the thrombus and resume aspiration.9.If flow is restricted or absent, maintain aspiration to make sure any thrombus or embolus is fully engaged with the distal tip of the sofia¿ catheter.With the thrombus or embolus fully engaged, slowly pull back the sofia¿ catheter and completely withdraw out of the patient.Warning: excessive aspiration with the distal tip of the sofia¿ catheter engaged with vessel wall may cause vessel injury.Investigation conclusion: the physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.

• Brand Name: SOFIA-6F
• Type of Device: PERCUTANEOUS CATHETER
• 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: 18899701
• MDR Text Key: 337619248
• Report Number: 2032493-2024-00216
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00842429108482
• UDI-Public: (01)00842429108482(11)230704(17)260630(10)0000388673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DA6131ST-ASP-US-OD
• Device Lot Number: 0000388673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2023
• 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
• Patient Outcome(s): Other