CODMAN CERTAS VALVES

Description of Event or Problem

A REVIEW OF EVENTS BETWEEN SEPTEMBER 2019 AND MARCH 2020 INVOLVING THE CODMAN VALVES AND CODMAN CATHETERS SHOWING: 1. INCREASE RATE OF INFECTIONS AND/OR RETURN TO OR WITHIN 30 DAYS AFTER VENTRICULOPERITONEAL SHUNT PLACEMENT/REVISION RELATED TO EITHER A CATHETER OR A VALVE ISSUES OF UNKNOWN REASONS: BEGAN USING A VARIETY OF CODMAN CERTAS VALVES (B)(6) 2018. BEGAN USING CODMAN BACTISEAL CATHETER (B)(6) 2019. IN DISCUSSIONS WITH THE NEUROSURGERY TEAM, THEY EXPRESSED CONCERNS ABOUT THE DESIGN AND FUNCTION OF THE PRODUCT. CURRENTLY, WE ARE IN COMMUNICATION WITH OUR CODMAN REPRESENTATIVE AND THE NEUROSURGEONS HAVE DECIDED TO LIMIT USE OF CODMAN BACTISEAL CATHETERS AND CERTAS VALVES, AS MUCH AS POSSIBLE WHILE INVESTIGATION IS BEING COMPLETED. FDA SAFETY REPORT ID #: (B)(4).