Safety Event Workflow

Dear {{CONTACT_NAME}}, Thank you for promptly notifying MedCore Clinical Research of the serious adverse event involving Subject {{SUBJECT_ID}} at {{SITE_NAME}} (Site {{SITE_NUMBER}}). We acknowledge receipt of your SAE report dated {{DATE}}. The event has been assigned the following identifier for tracking purposes: SAE Reference: {{SAE_ID}} Sponsor Awareness Date: {{AWARENESS_DATE}} Regulatory Reporting Deadline: {{DEADLINE_DATE}} Our safety team is currently reviewing the initial report. Please ensure that all relevant source documentation, including hospital discharge summaries, laboratory results, and any imaging reports, is available for review during the next monitoring visit or submitted electronically at your earliest convenience. If additional information becomes available regarding the subject's condition or the relationship of the event to the investigational device, please notify us immediately using the SAE follow-up form. We will keep you informed of any regulatory actions taken in relation to this event. Kind regards, {{CRA_NAME}} Clinical Research Associate {{SPONSOR_NAME}}

Dear {{CONTACT_NAME}}, We are writing in reference to the serious adverse event reported for Subject {{SUBJECT_ID}} at {{SITE_NAME}} (Site {{SITE_NUMBER}}), SAE Reference {{SAE_ID}}. Upon review of the initial SAE report, our pharmacovigilance team has identified the following outstanding information that is required to complete our safety assessment and fulfil regulatory reporting obligations under EU-MDR Article 87: {{QUERY_DETAILS}} Please provide this information by {{DEADLINE_DATE}} using the SAE Follow-Up Form (Appendix D of the study protocol PMCF-2024-CAT-001). Where hospital records or specialist reports are referenced, certified copies should be submitted alongside the completed form. Timely receipt of this information is essential to ensure compliance with competent authority reporting timelines. If you anticipate any difficulty in meeting this deadline, please contact me directly so that we may discuss interim arrangements. Thank you for your continued diligence in safety reporting for this study. Kind regards, {{CRA_NAME}} Clinical Research Associate {{SPONSOR_NAME}}

Dear Sir or Madam, Re: Serious Adverse Event Notification — PMCF Study PMCF-2024-CAT-001 Device: VascuPath 3F Interventional Catheter (Class IIb) Sponsor: MedCore Clinical Research In accordance with Article 87 of Regulation (EU) 2017/745 and MEDDEV 2.7/3, MedCore Clinical Research hereby notifies the competent authority of a serious adverse event that occurred during the above-referenced post-market clinical follow-up study. SAE Reference: {{SAE_ID}} Date of Event: {{EVENT_DATE}} Date Sponsor Became Aware: {{AWARENESS_DATE}} Investigating Site: {{SITE_NAME}} (Site {{SITE_NUMBER}}) Subject Identifier: {{SUBJECT_ID}} The initial SAE report form, completed in accordance with ISO 14155:2020 Section 10.3.2, is enclosed. A causality assessment has been performed, and the outcome is documented on the enclosed form. We will submit follow-up reports as additional information becomes available. Should you require any clarification or additional documentation, please contact the undersigned or MedCore Clinical Research's pharmacovigilance department. Respectfully, {{CRA_NAME}} On behalf of {{SPONSOR_NAME}} Regulatory Affairs and Safety Reporting

Dear {{CONTACT_NAME}}, URGENT — Field Safety Corrective Action Notification Study: PMCF-2024-CAT-001 — VascuPath 3F Interventional Catheter FSCA Reference: {{FSCA_ID}} MedCore Clinical Research is initiating a Field Safety Corrective Action (FSCA) affecting the VascuPath 3F Interventional Catheter units distributed to your site. This action is being taken in accordance with EU-MDR Article 83 and has been reported to the relevant competent authority. Nature of the Issue: {{FSCA_DESCRIPTION}} Required Actions at Your Site: {{REQUIRED_ACTIONS}} Affected Device Lot Numbers: {{LOT_NUMBERS}} Completion Deadline: {{DEADLINE_DATE}} Please acknowledge receipt of this notification within 24 hours by returning the enclosed FSCA Acknowledgment Form. All affected devices must be quarantined immediately pending further instruction. Do not use any device from the affected lots in study procedures until cleared by the sponsor. A member of our clinical monitoring team will contact you within 48 hours to verify implementation of the required corrective actions. If any affected devices have already been used in study procedures since {{DATE}}, please notify us immediately so that appropriate subject safety assessments can be conducted. This communication is confidential and should be shared only with authorised site personnel involved in study conduct. Kind regards, {{CRA_NAME}} Clinical Research Associate {{SPONSOR_NAME}}

Dear {{CONTACT_NAME}}, We are pleased to confirm that the serious adverse event involving Subject {{SUBJECT_ID}} at {{SITE_NAME}} (Site {{SITE_NUMBER}}) has been assessed as resolved. SAE Reference: {{SAE_ID}} Resolution Date: {{RESOLUTION_DATE}} Outcome: {{SAE_OUTCOME}} All regulatory reporting obligations associated with this event have been fulfilled. The final SAE report has been filed with the relevant competent authority, and no further follow-up submissions are anticipated. Please ensure that the subject's study file at your site is updated to reflect the resolution status. The SAE resolution documentation will be verified during the next scheduled monitoring visit. If the subject's condition changes or new information becomes available that may alter the causality assessment, please report this to MedCore Clinical Research without delay using the standard SAE reporting procedures outlined in the study protocol. Thank you for your thorough and timely reporting throughout the course of this event. Kind regards, {{CRA_NAME}} Clinical Research Associate {{SPONSOR_NAME}}