MAUDE Adverse Event Report: MICROVENTION INC. SOFIA 6F-131CM STR; CATHETER, INTRAVASCULAR DIAGNOSTIC

Model Number	DA6131ST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported from the sofast study, the patient experienced a right aca infarct, ae # 001.Mra showed small infarct in posterior distal branches of right aca.Intervention was aca thrombectomy.Patient presented as direct admit from osh following stemi with placement of des in lad same day.On arrival patient had nihss of 18 with mutism, left hemiplegia and right hemiparesis.Right mca superior division occlusion was found as well as a left mca inferior stenosis, and developing hypo density.Patient was taken for thrombectomy.Reported prior medical history included previous stroke and residual speech deficits.Hospital course was further complicated by pneumonia that contributed towards patient's dependence on ventilation, and nonocclusive thrombosis found in the left common femoral.On (b)(6) 2023 the patient's wife asked for patient to be transitioned to inpatient hospice.The patient passed away (b)(6) 2023.Subject 17-008 ae # 001-right aca infarct was determined "possibly related to the sofia device." index procedure was (b)(6) 2023.Please note, it is documented "event pneumonia event number # 17-008-003 on post operative day 2, with outcome of death, not related to procedure or device." two lots are listed for the sofia and used on the same patient.On index procedure day (b)(6) 2023 subject had 2 passes of aspiration with sofia devices; lot 0000342746 and final pass of aspiration was with lot 0000251792.As it cannot be determined which device was possibly related to the infarct issue, both lots will be listed, one as primary and one as ancillary.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The alleged aca infarction and issues as described could not be confirmed.A search for non-conformances associated with both sofia part/lot number combinations provided did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the devices.
Event or Problem Description
No additional information was received, please see h6 and h10.
Additional 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, 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): potential complications: potential complications include but are not limited to: 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 flow plus aspiration catheter to reduce the chance of accidental damage.Use caution when manipulating the sofia flow plus aspiration catheter in tortuous vasculature to avoid damage.Avoid advancing or withdrawal against resistance until the cause of resistance is determined.The presence of calcification, irregularities, or other devices may damage the sofia flow plus aspiration catheter and potentially affect its insertion or removal.Maintain perfusion of heparinized saline for inner lumen of the sofia flow plus aspiration catheter to prevent thrombus formation.Do not use automated high-pressure contrast injection equipment with the sofia flow plus aspiration catheter because it may damage the catheter.The catheter has hydrophilic coating over the distal 60 cm.Make sure to hydrate the coating before use with heparinized saline.Once the catheter is hydrated, do not allow it to dry.Delivery of the sofia flow plus aspiration catheter: 6.Navigation through the vasculature.B.Insert the guidewire and / or microcatheter into the sofia flow plus aspiration catheter and advance the guidewire / microcatheter until the guidewire / microcatheter and the sofia flow plus aspiration catheter are aligned at the distal end.C.Using the introducer sheath provided in the package, carefully insert the sofia flow plus aspiration catheter and the guidewire through a hemostatic valve of the femoral sheath.Warning: do not over-tighten the hemostatic valve on the sheath or guide catheter through which the sofia flow plus aspiration catheter is inserted.Over-tightening may result in damage to the sofia flow plus aspiration catheter.E.Under fluoroscopic guidance, advance or withdraw the sofia flow plus aspiration catheter over the guidewire and / or microcatheter until the desired position is attained.Select vessels by slowly torqueing the sofia flow plus aspiration catheter if necessary.Warning: do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined.Warning: torqueing the sofia flow plus aspiration 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.Aspiration through the sofia flow plus aspiration catheter 8.Under fluoroscopic guidance, position the distal tip of the sofia flow plus aspiration catheter at the desired vessel location.Warning: do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined.Warning: torqueing the sofia flow plus aspiration catheter excessively while kinked may damage the catheter resulting in separation of the catheter.Withdraw the catheter system, including the sofia flow plus aspiration catheter, microcatheter, and guidewire if the sofia flow plus aspiration catheter is severely kinked.9.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.13.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.14.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 flow plus aspiration catheter to engage the thrombus and resume aspiration.15.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 flow plus aspiration catheter.With the thrombus or embolus fully engaged, slowly pull back the sofia flow plus aspiration catheter and completely withdraw out of the patient.Warning: excessive aspiration with the distal tip of the sofia flow plus aspiration catheter engaged with vessel wall may cause vessel injury.16.With the sofia flow plus aspiration catheter outside of the patient body, flush the catheter to clear the catheter of any thromboembolic material that may be inside.Warning: do not attempt to clear inner lumen of the sofia flow plus aspiration catheter by infusion while keeping the device in the patient body.Remove the sofia flow plus aspiration catheter from the patient body before attempting to clear the lumen.17.If repeated access to the vasculature with the same device is desired, flush and clean the inner lumen of the device by infusion.Inspect the device for any damage.Reintroduce the sofia flow plus aspiration catheter into the body and follow steps 6 & 7 in the ¿delivery of the sofia flow plus aspiration catheter¿ section to navigate the catheter to the target site.Warning: do not use the device if any damage or irregularities are observed.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.
Additional Manufacturer Narrative
H11- udi related data quality updates only.Upon review of device registrations and mdrs submitted to the fda, discrepancies were noted.Clarification was received regarding the device registration and the following fields have been corrected: d1, d2a, d2b, d3, d4, g5.The corrected information does not have any impact on the incident or investigative data submitted on earlier reports.The h6 codes and h11 investigation results stand as previously submitted.
Event or Problem Description
No additional information received.This report represents corrections to a previously submitted mdr.Fields corrected (udi related data quality updates) are listed in h11.

• Brand Name: SOFIA 6F-131CM STR
• Common Device Name: CATHETER, INTRAVASCULAR DIAGNOSTIC
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18303253
• Report Number: 2032493-2023-01104
• Device Sequence Number: 4144748
• Product Code: DQO
• UDI-Device Identifier: 00842429108482
• UDI-Public: (01)00842429108482(11)220829(17)250731(10)0000251792
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2024
• 2 Devices were Involved in the Event: 1 2

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: 07/31/2025
• Device Model Number: DA6131ST
• Device Lot Number: 0000251792
• 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: 11/18/2023
• Supplement Date Received by Manufacturer: 12/12/2023; 07/09/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 12/18/2023; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SOFIA FLOW 5F -125CM LOT 0000342746
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male