BACKSTOP CLEAR GEL WITH 3R CATHETER

Description of Event or Problem

BACKSTOP GEL IS A SELF-FORMING POLYMERIC PLUG WITH REVERSE THERMOSENSITIVE PROPERTIES. WHEN THE TEMP OF THE GEL INCREASES, ITS VISCOSITY INCREASES AND IT FORMS A PLUG THAT IS INTENDED FOR USE IN THE URETER TO PREVENT MIGRATION OF RENAL CALCULI DURING INTRACORPOREAL LITHOTRIPSY PROCEDURES. THE MATERIAL IS WATER SOLUBLE AND IS REMOVED BY IRRIGATING THE PLUG WITH SALINE. REPORT RECEIVED FROM A PHYSICIAN VIA DISTRIBUTOR ON (B)(4) 2012 REGARDING AN UNIDENTIFIED, PT WHO UNDERWENT URETEROSCOPY PROCEDURE THAT WAS PERFORMED ON (B)(6) 2012. THE PT WAS TREATED WITH BACKSTOP. THE DOSE, LOCATION, AND TIME OF RESIDENCE WAS NOT PROVIDED. THE PT WAS ALSO TREATED WITH LEVEQUIN IMMEDIATELY POSTOPERATIVELY AND DISCHARGED THAT EVENING. POST PROCEDURE, THE NEXT DAY, THE PT WENT TO THE ER WITH FACIAL SWELLING AND WAS PLACED IN ICU. THE PHYSICIAN WAS CONCERNED IT MIGHT BE AN ALLERGIC REACTION TO THE BACKSTOP MATERIAL OR THE LEVEQUIN THAT WAS ADMINISTERED TO THE PT. F/U INFO RECEIVED ON 5/4/2012 INDICATED THE PHYSICIAN DID NOT HAVE ANY FURTHER CLARIFICATION OF WHICH OF THE TWO SUSPECTED MATERIALS CAUSED THE ALLERGIC REACTION, LEVEQUIN WAS ADMINISTERED IMMEDIATELY POST CASE. THERE WERE NO SIGNS OF ALLERGIC REACTION FOLLOWING THE (B)(6) 2012 PROCEDURE. THE SALES REP ALSO REPORTED THAT SOMETHING WAS GIVEN TO THE PT ON (B)(6) 2012 TO HELP WITH THE SWELLING ON BUT DID NOT KNOW WHAT IT WAS. ON (B)(6) 2012, THE PT LEFT HOSP AND HIS CONDITION WAS REPORTED TO BE "FINE."