CAVACLEAR LASER SHEATH

Additional Manufacturer Narrative

A2) PATIENT'S DATE OF BIRTH - NOT AVAILABLE FROM FACILITY. A4) PATIENT'S WEIGHT - NOT AVAILABLE FROM FACILITY. B6/B7) PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY - NOT AVAILABLE FROM FACILITY. D4/H4) THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION IS UNKNOWN: DEVICE SERIAL NUMBER, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. G4) 510K/PMA NUMBER IS NOT APPLICABLE. DE NOVO NUMBER: DEN210014. H3) THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED. H6) GREAT VESSEL PERFORATION IS A KNOWN RISK OF COMPLICATION WITH USE OF THE CAVACLEAR DEVICE. 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 (IVC) FILTER REMOVAL COMMENCED BECAUSE THE PATIENT WAS EXPERIENCING ABDOMINAL PAIN, DUE TO THE FILTER¿S STRUTS PENETRATING OUTSIDE THE IVC VEIN. BEGINNING WITH A SPECTRANETICS CAVACLEAR LASER SHEATH, THE DEVICE WAS ABLE TO SUCCESSFULLY COLLAPSE THE FILTER, BUT THE STRUTS WOULD NOT GIVE, DESPITE BEING FULLY IN THE CAVACLEAR. AFTER SOME TRACTION AND PERSISTENT LASING, THE STRUTS FINALLY RELEASED. THE CAVACLEAR ADVANCED SLIGHTLY FORWARD; HOWEVER, AN IVC PERFORATION OCCURRED. RESCUE EFFORTS BEGAN, INCLUDING A BALLOON TO TREAT THE PERFORATION. THE IVC HEALED, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE CAVACLEAR IN USE WHEN THE IVC PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE CAVACLEAR DEVICE IN USE DURING THE PROCEDURE.