CAVACLEAR LASER SHEATH

Additional Manufacturer Narrative

A3B) PATIENT GENDER - NOT AVAILABLE FROM FACILITY. D4) DEVICE SERIAL NUMBER UNKNOWN. G4) 510K/PMS NUMBER IS NOT APPLICABLE. DE NOVO NUMBER: (B)(4). H3/H6) THE CAVACLEAR WAS DISCARDED, THUS NO PRODUCT INVESTIGATION WAS PERFORMED AND THE CAUSE OF THE REPORTED FAILURE COULD NOT BE ESTABLISHED. 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.

Description of Event or Problem

AN INFERIOR VENA CAVA FILTER (IVCF) PROCEDURE COMMENCED TO REMOVE A CORDIS OPTEASE OPTIONAL IVCF DUE TO NO LONGER INDICATED. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO TREAT THE PATIENT. DURING USE, WHEN THE CAVACLEAR WAS BEING ROCKED BACK AND FORTH TO THE FILTER, IT WAS NOTICED THAT THE DISTAL TIP FRAYED, EXPOSING THE FIBERS. A SECOND 16F CAVACLEAR WAS UTILIZED; HOWEVER, THE SAME MALFUNCTION OCCURRED (MDR #3007284006-2025-00240). THEN, A THIRD 16F CAVACLEAR WAS USED, AND EXPERIENCED THE SAME ISSUE (MDR #3007284006-2025-00241). THE PROCEDURE WAS COMPLETED MANUALLY WITH FORCEPS, WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.