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