Safety Event Workflow

Dear {{CONTACT_NAME}}, Thank you for reporting the product complaint related to the VascuPath 3F Interventional Catheter at {{SITE_NAME}} (Site {{SITE_NUMBER}}). Your complaint has been logged in the MedCore Clinical Research complaint management system and assigned the following reference: Complaint Reference: {{COMPLAINT_ID}} Date Received: {{DATE}} Device Lot Number: {{LOT_NUMBER}} Our quality assurance team will conduct a preliminary assessment within five business days to determine the nature and scope of the reported issue. You will be notified of the investigation outcome and any required corrective actions. In the meantime, please retain the affected device and any associated packaging in its current condition. If the device has been used in a study procedure, please document any observed deviations from expected performance in the subject's case report form and source documentation. If you believe this complaint is associated with a serious adverse event or poses an immediate risk to subject safety, please also submit an SAE report in accordance with Section 9.4 of the study protocol PMCF-2024-CAT-001. Kind regards, {{CRA_NAME}} Clinical Research Associate {{SPONSOR_NAME}}

Dear {{CONTACT_NAME}}, This letter confirms that a formal investigation has been initiated for the product complaint submitted by {{SITE_NAME}} (Site {{SITE_NUMBER}}). Complaint Reference: {{COMPLAINT_ID}} Investigation Start Date: {{DATE}} Target Completion Date: {{DEADLINE_DATE}} The investigation will be conducted by MedCore Clinical Research's quality and engineering teams in accordance with our complaint handling SOP (QMS-PRO-007) and the requirements of EU-MDR Annex I, Section 20. The investigation scope includes: - Root cause analysis of the reported device malfunction or performance issue - Review of manufacturing batch records for the affected lot - Assessment of any potential impact on other devices from the same production batch - Determination of whether the complaint meets the threshold for trend reporting under the manufacturer's post-market surveillance plan We may contact you during the investigation to request additional details or to arrange return of the affected device for laboratory analysis. If device return is required, we will provide a prepaid shipping label and specific handling instructions. You will receive a written summary of the investigation findings upon completion. Kind regards, {{CRA_NAME}} Clinical Research Associate {{SPONSOR_NAME}}

Dear {{CONTACT_NAME}}, We are writing to inform you of the outcome of the investigation into the product complaint reported by {{SITE_NAME}} (Site {{SITE_NUMBER}}). Complaint Reference: {{COMPLAINT_ID}} Investigation Closure Date: {{DATE}} Investigation Findings: {{INVESTIGATION_FINDINGS}} Corrective Actions Taken: {{CORRECTIVE_ACTIONS}} Risk Assessment Outcome: The investigation concluded that the reported issue {{RISK_CONCLUSION}}. This determination has been documented in the post-market surveillance technical file for the VascuPath 3F Interventional Catheter in accordance with EU-MDR Article 83. No further action is required from your site unless otherwise indicated above. The complaint record will be retained in the sponsor's quality management system for the regulatory retention period. If you observe any recurrence of the reported issue or have questions regarding the investigation outcome, please do not hesitate to contact us. Kind regards, {{CRA_NAME}} Clinical Research Associate {{SPONSOR_NAME}}

Dear {{CONTACT_NAME}}, We are following up on the product complaint submitted by {{SITE_NAME}} (Site {{SITE_NUMBER}}), Complaint Reference {{COMPLAINT_ID}}. To progress our investigation, we require the following additional information: {{QUERY_DETAILS}} Please provide the requested information by {{DEADLINE_DATE}}. If you are unable to obtain certain items within this timeframe, please let us know so that we can adjust the investigation timeline accordingly. Where applicable, please ensure that any documentation provided is legible, dated, and signed by the appropriate site personnel. Photographs of the device or packaging defect, if available, would also be helpful. Your cooperation is appreciated. Kind regards, {{CRA_NAME}} Clinical Research Associate {{SPONSOR_NAME}}