ACIST

Description of Event or Problem

DURING THE THIRD TRIAL, USING THE ACIST RXI AND NAVVUS CATHETER, THE USER ATTEMPTED TO MEASURE THE DISTAL RESIDUAL LESION OF THE TARGET, THERE WAS RESISTANCE, AND THE CATHETER COULD NOT CROSS. THE RXI SYSTEM DISPLAYED A WARNING MESSAGE AND THE NAVVUS WAS REMOVED FROM THE PATIENT. UPON REMOVAL OF THE NAVVUS CATHETER, IT WAS OBSERVED THAT THE CATHETER WAS BROKEN. THE PIECE OF CATHETER REMAINING WITHIN THE PATIENT'S VASCULATURE WAS COLLECTED WITH A SNARE WIRE. A NEW NAVVUS CATHETER WAS USED AND THE LESION WAS CROSSED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THE NAVVUS CATHETER WAS BROKEN AT THE LOCATION OF THE CURVE CROSSING THE COMMON ILIAC ARTERY BIFURCATION. THE VESSEL WAS NOT TORTUOUS AND DID NOT CREATE ANY TENSION. THE PHYSICIAN COMMENTED THAT THE CATHETER BREAK WAS LIKELY CAUSED WHEN MOVING THROUGH A HAIRPIN-LIKE CURVE WITHIN THE VASCULATURE.

Additional Manufacturer Narrative

THE NAVVUS CATHETER, LOT NUMBER 0000185531, IS BEING DELIVERED FOR INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

Additional Manufacturer Narrative

CORRECTION FOR INITIAL MEDWATCH MADE TO FIELD H5. DEVICE IS LABELED FOR SINGLE USE. ON JULY 8, 2022, THE ACIST NAVVUS II CATHETER WAS INVESTIGATED. THE CATHETER WAS SEPARATED 34CM FROM THE DISTAL TIP. THIS CONFIRMED THE REPORTED COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO DEVIATIONS TO THE SPECIFICATION OR MANUFACTURING PROCESS WERE PRESENT DURING MANUFACTURING. ON JULY 7, 2022 THE ACIST MEDICAL ADVISORY BOARD MEMBER PROVIDED THE FOLLOWING CLINICAL ASSESSMENT: DIAGNOSTIC IMAGES WERE OBTAINED FROM THE ARM ACCESS AND SUBSEQUENTLY FROM THE LEFT COMMON FEMORAL. INTERVENTION WAS PERFORMED ON THE RIGHT SUPERFICIAL FEMORAL ARTERY, AND A BALLOON WAS USED DURING THE PROCEDURE. THE ACIST NAVVUS II CATHETER WAS USED TO MEASURE THE GRADIENTS. THE NAVVUS II CATHETER FRACTURED WHEN CROSSING THE AIB. THE IMAGES SHOW THE DISTAL END OF THE CATHETER BEING REMOVED WITH A SNARE. A MILD TYPE 1 DISSECTION ALONG THE ANGIOPLASTY SITE WAS SEEN AND IS NOTED TO BE TYPICAL WITH THIS TYPE OF INTERVENTION. THIS TYPE OF DISSECTION DOES NOT REPRESENT A FAILURE OF THE NAVVUS II CATHETER OR A COMPLICATION OF THE INTERVENTION.