Navilyst Medical, Inc. Global Complaints System Complaint Notification Form (CNF) Blue underlined fields are required prior to submitting the form within 3 working days to the CCC Completed By: Completed On: (dd/mmm/yyyy) Please remind the person reporting the complaint about an important personal data protection responsibility for the hospital/doctor involved in the complaint under applicable law in certain locations. Some laws require the patient to be informed by the hospital/doctor that data from the complaint will be used by Navilyst Medical in a database of product performance reports. Complaint Information General Information Is Clinical? - If the complaint is related to a Post Market Clinical or Pre-Market Clinical study, answer YES Yes No If yes, name of clinical Trial Contact Information Complaint Reporter Phone: Complaint Reporter Name: Complaint Reporter Job Title: Physician Phone: Physician Name: (in some cases the reporter could be the physician himself) Physician/Nurse Email Address : First Navilyst Contact Name: Navilyst Aware Date: ( date when the Navilyst first contact person heard about the complaint) Complaint Notification Date: (date when the complaint was received at the CCC) CNF Electronic CNF Email Fax FSR Mail Contact Method: Complaint Source: Animal Study Navilyst Employee Navilyst Sales Rep Distributor End User Field Service Health Professional Legal Literature Market Evaluation Forms Patient Physician Preference Evaluation Telephone Voicemail Other Pre-Market Clinical Study Post Market Study Regulatory Authority Regulatory Report R&D Study User Facility Other Sold To Distributor’s Sold to Customer: Navilyst Sold To Name or Account Number: Distributor’s Sold to Customer City: Navilyst Complainant City: Customer Investigation Response Letter Requested? Communications Yes No If yes, send to _________________________ Product/Batch Information UPN description (required if UPN is unknown): Batch/Lot/Serial # (if not know, enter UNKNOWN): Is this a single use device? Yes No Product Detail UPN# (if not know, enter UNKNOWN): Re-sterilized? (Reprocessed) If reprocessed and used on patient specify reprocessor name and address: Used past expiry date? Yes No Yes N/A No N/A THIS DOCUMENT IS THE PROPERTY OF NAVILYST MEDICAL, INC. AND SHALL NOT BE REPRODUCED, DISTRIBUTED, DISCLOSED OR USED FOR MANUFACTURE OR SALE OF APPARATUS WITHOUT THE EXPRESS WRITTEN CONSENT OF NAVILYST MEDICAL, INC. Navilyst Medical Complaint Notification 90108350 Rev/Ver. AK Page 1 of 3 Product Movement Product Expected? Reason for no Return: Yes No No Information Available Contaminated Disposed Implanted Quantity Expected: Retained Implanted Patient Information Is patient/user under 18? Patient Age at Time of Event: Patient Sex: M F Unknown Significant past medical history/ patient comorbidities (if any) Multivessel disease Trauma to chest Yes Anatomy or lesion Location: Diabetes - Insulin dependant? Y N Renal Disease Congestive Heart Failure Does patient have known allergy to stainless steel? Yes No N/A No Other Specify N/A Coagulation Disorder (specify) Cancer Other (specify) Not Applicable or Unknown Any other known allergies? Yes No If yes, list: Does patient have known sensitivity to any drugs? Yes No Was patient immunocompromised? Yes No Does patient have a contraindication to anti-platelet or anticoagulation therapy? Yes No Medications used Pre-procedure? During procedure? Post-procedure and how long? Procedure Information Initial Procedure Date: Procedure Name Indication of procedure : Procedure Outcome: Completed with this device Completed with another same device Completed with a different device Aborted due to this event Aborted due to same device unavailable Not completed due to another reason No information available What was the patient condition following procedure? Event Date: When was the problem noticed: Procedure Closure Unpacking Post Procedure Where did the problem occur? stable surgery Event Information Event Country: Preparation death Introduction Other - specify During Procedure Withdrawal No Information Available Inside the patient Outside the patient Not Applicable No Information Available Event Description: Is this a known/possible adverse event? Yes No Was the problem associated with labeled use? Yes No If no, explain: Blood/Blood products (describe)…… Other Intervention ((Describe….)… Surgery (Describe)… Hospitalization or prolongation of Device removed hospitalization (length of stay & reason) None __________ Action taken by the physician to try to resolve the event (Check all that apply): Observation: Medications (Describe)….. Permanent impairment of a body Patient outcome from the event Death Date __________ function(describe) If Death, Autopsy report/death Serious injury (describe) certificate available. . Event resolved? Yes No Unknown Physician assessment of the relationship of the event to the device Unrelated No serious injury(describe) No information available None Unlikely to be related Related Unknown Navilyst Medical Complaint Notification 90108350 Rev/Ver. AK Page 2 of 3 Other possible contributing factors to the event Procedure Co-morbidity Please check all those that can be forwarded to Navilyst CT Scan X-ray Discharge notes Other – specify Other – Specify___________________ Angio Cine Procedure Notes Complaint Call Center (CCC) United States Complaint Call Center Glens Falls Phone: 800-833-9973 Fax: 800-782-1357 e-mail: navilystcomplaintmailbox@navilyst.com Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls NY 12801 Navilyst Medical Complaint Notification 90108350 Rev/Ver. AK Page 3 of 3