WAVELINQ 4FR P

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (B)(4) THAT TWENTY-EIGHT DAYS POST AN ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION USING THE WAVELINQ, A SECOND STAGE PROCEDURE, BALLOON ASSISTED MATURATION, WAS PERFORMED TO SUPPORT MATURATION. A NEW STENOSIS WITH EIGHTY PERCENTAGE WAS IDENTIFIED IN THE RADIAL ARTERY, PROXIMAL TO THE ENDOAVF ANASTOMOSIS. POST PROCEDURE, THE STENOSIS WAS REDUCED TO TEN PERCENTAGE. ANOTHER NEW STENOSIS WITH EIGHTY PERCENTAGE WAS IDENTIFIED IN THE CEPHALIC VEIN, PROXIMAL TO THE ENDOAVF ANASTOMOSIS. POST PROCEDURE, THE STENOSIS WAS REDUCED TO TEN PERCENTAGE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.