BARD SNARE RETRIEVAL KIT

Description of Event or Problem

IT WAS REPORTED THAT PRIOR TO THE SNARE RETRIEVAL PROCEDURE, AN OPENING WAS ALLEGEDLY FOUND AT THE EDGE OF THE SEAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

Additional Manufacturer Narrative

THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT THE DEVICE HAS MALFUNCTIONED OR THAT THE DEVICE WAS RELATED TO A DEATH OR INJURY. COMPLAINT INVESTIGATION RESULTS: ACCORDING WITH THE EVENT DESCRIPTION PROVIDED BY THE CUSTOMER, THE PICTURES AND SAMPLE EVALUATION, AND DHR REVIEW IT CAN BE CONCLUDED THE REPORTED EVENT CANNOT BE CONSIDERED AS A MANUFACTURER RELATED ISSUE, BASED ON THE FOLLOWING FACTS: NO DEVIATIONS TO ESTABLISHED PROCEDURES OR NONCONFORMANCES RELATED TO THE EVENT DESCRIPTION WERE IDENTIFIED IN THE RECORD REVIEW. EVALUATING THE PICTURES AND SAMPLE PROVIDED BY THE CUSTOMER, IT WAS FOUND EVIDENCE THAT EXCESS OF FORCES, CAUSED DUE TO AN INADEQUATE HANDLING, COULD DAMAGE THE PRODUCT, BACKER CARD AND POUCH SURFACES. IN-PROCESS CONTROLS ARE CONSIDERED ROBUST ENOUGH TO DETECT SIMILAR DAMAGES DURING THE PACKAGING AND SEALING PROCESSES OF THE SNARE KIT. THIS IS THE FIRST EVENT REPORTED FOR SIMILAR ISSUES. THE PROCESS CONTROLS ESTABLISHED IN RISK MANAGEMENT DOCUMENTATION OF SIMILAR FAILURE MODES, WERE REVIEWED AND NOT DEVIATIONS OR NONCONFORMANCES RELATED TO THEM WERE IDENTIFIED THEREFORE, THERE IS NO EVIDENCE TO CONFIRM THE ISSUE IS DUE TO THE MANUFACTURING PROCESS.