Description of Event or Problem · 1
ESSURE DEVICE DID NOT DEPLOY COMPLETELY, STUCK IN FALLOPIAN TUBE WITH PLASTIC SHEATH CAUSING BLEEDING. DEVICE BAGGED FOR FURTHER INVESTIGATION. SURGEON STATES DISCLOSURE TO PT FAMILY, DOES NOT FEEL THERE WILL BE A NEED FOR FURTHER PROCEDURE. REP CONTACTED DURING PROCEDURE FOR SUPPORT/IDEAS. DR (B)(6) ALSO CAME TO ROOM FOR CONSULTATION AS HE USES THIS SYSTEM. SURGEON FELT THERE WAS NOTHING THAT COULD HAVE BEEN DONE PRIOR TO OR DURING FOR PREVENTION OF INCIDENT. UPON WHEELING BACK, THE ESSURE DEVICE, FOLLOWING DEPLOYMENT, THE TRAILING END OF THE WIRE REMAINED ATTACHED TO THE COILS AND THIS RESULTED IN AN EXCESSIVE AMOUNT OF WIRE LEFT WITHIN THE UTERINE CAVITY. THE WIRE INCLUDED THE GREEN PLASTIC COVERING. IN ORDER TO REMOVE THIS TRAILING WIRE FROM THE UTERINE CAVITY, THE OPERATIVE HYSTEROSCOPE NEEDED TO BE EXCHANGED FOR AN OPERATIVE CYSTOSCOPE, WHICH COULD ACCOMMODATE A LARGER SCISSOR. ONCE THE CYSTOSCOPE WAS SET UP, WAS PLACED WITHIN THE PT'S UTERINE CAVITY, THE CYSTOSCOPIC SCISSORS WERE USED TO TRIM THE WIRE SO THAT THE TRAILING END OF THAT WIRE OFF THE COILS WAS NEARLY FLUSH WITH THE TUBAL OSTIA, APPROX 2 COILS OF THAT WIRE REMAINED TRAILING FROM THE OSTIA SITE. THIS CONCLUDED THE PROCEDURE. EVENT ABATED AFTER USE STOPPED: YES. DIAGNOSIS OR REASON FOR USE: HYSTEROSCOPY WITH ESSURE.