WAVELINQ 4FR P

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE SAMPLE HAS NOT BEEN 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) ARE 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 THREE MONTHS POST AN ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION USING THE WAVELINQ 4FR P, THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED BY PHYSICAL ASSESSMENT. IT WAS FURTHER REPORTED THAT, TWENTY-FIVE DAYS LATER, A POST-PROCEDURE INTERVENTION WAS PERFORMED FOR STENOSIS AT THE PERFORATOR VESSEL, WHEREIN THE INITIAL STENOSIS WAS FORTY SIX PERCENT AND THE FINAL RESIDUAL STENOSIS WAS ZERO PERCENT. TWO DAYS LATER, A SECOND POST-PROCEDURE INTERVENTION WAS PERFORMED DUE TO INSUFFICIENT ENDOAVF MATURITY. ONE MONTH AND TWENTY-THREE DAYS LATER, A THIRD POST-PROCEDURE INTERVENTION WAS PERFORMED AT THE PROXIMAL LOCATION, WHERE THE INITIAL STENOSIS WAS NINETY NINE PERCENT AND REDUCED TO ZERO PERCENT, AND ADDITIONALLY FOR STENOSIS AT THE BASILIC VEIN, THE INITIAL PERCENTAGE WAS EIGHTY NINE PERCENT AND THE FINAL STENOSIS WAS ZERO PERCENT. TWO MONTHS AND TWENTY-THREE DAYS LATER, A FOURTH POST-PROCEDURE INTERVENTION WAS PERFORMED FOR STENOSIS AT THE BASILIC VEIN, WITH AN INITIAL STENOSIS OF NINETY NINE PERCENT REDUCED TO ZERO PERCENT, AND ADDITIONALLY FOR STENOSIS AT THE INNOMINATE VESSEL AT PROXIMAL LOCATION, THE INITIAL STENOSIS WAS SEVENTY NINE PERCENT AND THE FINAL STENOSIS WAS ZERO PERCENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.