CAVACLEAR LASER SHEATH

Description of Event or Problem

AN INFERIOR VENA CAVA FILTER (IVCF) REMOVAL PROCEDURE COMMENCED TO REMOVE A GREENFIELD PERMANENT ICVF, DUE TO SYMPTOMS OF BACK PAIN AND REQUEST FOR REMOVAL. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO TREAT THE PATIENT. AFTER USING THE CAVACLEAR FOR TWO CYCLES, IT WAS NOTED THAT THE BIFURCATE HANDLE WAS GENERATING HEAT, AND UPON REMOVAL, EXPOSED FIBERS WERE OBSERVED NEAR THE HANDLE. A NEW 16F CAVACLEAR WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORT PATIENT OR USER HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

Additional Manufacturer Narrative

G4): 510K/PMA NUMBER IS NOT APPLICABLE. DE NOVO NUMBER: DEN210024. H3): THE CAVACLEAR DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND A KINK IN THE OUTER JACKET, JUST PROXIMAL TO THE BIFURCATE HANDLE. IN THE AREA OF THE KINK, THE OUTER JACKET WAS MELTED AND BREACHED, WITH BROKEN AND EXPOSED FIBERS OBSERVED. H6): BASED ON THE DEVICE EVALUATION AND INVESTIGATION, THIS HAS BEEN DETERMINED TO BE A USE RELATED FAILURE. HISTORICALLY, THE MANUFACTURER HAS SEEN THIS FAILURE NEAR THE BIFURCATE WHEN EXCESSIVE FORCES ARE APPLIED TO THE SIDE OF THE OUTER JACKET AT OR NEAR THE BIFURCATE. THE DEVICE BECOMES KINKED, AND THEN BROKEN FIBERS AT THE AREA OF THE KINK PRODUCE HEAT, WHICH CREATES A BREACH IN THE OUTER JACKET. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.