Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A STANDARD WATCHMAN PROCEDURE, PRE-IMAGING WAS COMPLETED WITH CT, DOAC (COMPUTED TOMOGRAPHY, DIRECT ORAL ANTICOAGULANTS) (APIXABAN) WAS HELD FOR TWO DAYS PRIOR TO PROCEDURE DAY, AND HEPARIN WAS GIVEN PRIOR TO CROSSING THE SEPTUM (9000 UNITS). INTERATRIAL SEPTUM WAS NOTED TO BE FIBROTIC, REQUIRING THREE APPLICATIONS OF RADIOFREQUENCY (RF) FOR THE NEEDLE AND THE WIRE TO CROSS INTO THE LEFT ATRIUM. ADDITIONAL HEPARIN WAS ADMINISTERED (4000 UNITS) AND THE DILATOR REMAINED TO TENT ON THE SEPTUM DESPITE SEVERAL ATTEMPTS TO CROSS. THE PHYSICIAN THEN STARTED TO PREPARE TO BALLOON THE SEPTUM WHEN A MOBILE ECHOGENIC DENSITY WAS NOTED TO BE ATTACHED TO THE WIRE IN THE LEFT ATRIUM. ADDITIONAL HEPARIN GIVEN (2K) WITH SUBSEQUENT ACT OF 259 THEN ADDITIONAL HEPARIN GIVEN (2000, 2000, 2000 UNITS). DURING THE NEXT FEW STEPS ADDITIONAL ACTS WERE DRAWN (295,332). MECHANICAL ASPIRATION WAS ATTEMPTED UNSUCCESSFULLY. PRIOR TO CONTINUING TO ASPIRATE SENTINEL PROTECTION WAS USED VIA RIGHT RADIAL ARTERY ACCESS. ONCE SENTINEL PROTECTION IN PLACE, PHYSICIAN PULLED THE WIRE OUT OF LEFT ATRIUM (LA). AND PULLED THE DILATOR FROM THE RIGHT ATRIUM (RA). TRANSESOPHAGEAL ECHO WAS THEN USED TO EVALUATE THE LA AND THE PRESENCE OF POSSIBLE THROMBUS WHICH WAS NOT APPRECIATED. STANDARD WATCHMAN PROCEDURE WAS THEN PURSUED WITHOUT COMPLICATION. NO NEUROLOGICAL DEFICIT WAS NOTED IN LAB AFTER END OF PROCEDURE. IT IS SUSPECTED THAT THE THROMBUS WAS DUE TO THE THREE RF APPLICATIONS. EXCESSIVE FORCE WAS NOT USED TO GAIN FEMORAL ACCESS. NO IMAGING DIFFICULTIES WERE NOTED. NO COMPLEX ANATOMY APPRECIATED OTHER THAN PROBABLY MILD TO MODERATE BI-ATRIAL ENLARGEMENT. THREE APPLICATIONS OF RF WERE APPLIED BEFORE SUCCESSFUL TRANSSEPTAL PUNCTURE. THE PUNCTURE LOCATION WAS INFERIOR & MID IN THE SEPTUM. THE PATIENT WAS ADMITTED FOR SUPERVISION LIKELY OVERNIGHT. NOTE: NO WATCHMAN PRODUCTS (DEVICE OR SHEATHS) WERE IN PATIENT AT TIME OF THIS COMPLICATION. THE PATIENT WAS DISCHARGED, THERE WERE NO OTHER PATIENT COMPLICATIONS. SALES REP BELIEVES THAT A NONBOSTON SCIENTIFIC SHEATH (PREFACE SHEATH) AND NRG WERE USED FOR THIS CASE, NOT A NON-BOSTON SCIENTIFIC (BRK). THE NRG NEEDLE WAS THE ONLY BOSTON SCIENTIFIC DEVICE USED FOR TRANSSEPTAL ACCESS. THE STATEMENT "DILATOR REMAINED TO TENT ON THE SEPTUM DESPITE SEVERAL ATTEMPTS TO CROSS" WAS REFERRING TO THE DILATOR ON THE SEPTUM, THE DILATOR NEVER CROSSED THE SEPTUM INTO THE LA. THE DILATOR WAS A NON-BOSTON SCIENTIFIC DEVICE (PREFACE & NRG USED). IT IS SUSPECTED THAT THE THROMBUS WAS DUE TO THE THREE RF APPLICATIONS. EXCESSIVE FORCE WAS NOT USED TO GAIN FEMORAL ACCESS. NO IMAGING DIFFICULTIES WERE NOTED. NO COMPLEX ANATOMY APPRECIATED OTHER THAN PROBABLY MILD TO MODERATE BI-ATRIAL ENLARGEMENT. THREE APPLICATIONS OF RF WERE APPLIED BEFORE SUCCESSFUL TRANSSEPTAL PUNCTURE. THE PUNCTURE LOCATION WAS INFERIOR & MID IN THE SEPTUM. IT HAS BEEN CONFIRMED BY SALES REP THAT THE DILATOR IS A NON-BOSTON SCIENTIFIC DEVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).