BANDER URETERAL DIVERSION STENT SET

Additional Manufacturer Narrative

D2A: CATHETER, NEPHROSTOMY. D2B: LJE. E1 - TITLE: BSN, RN, MS, CNOR NURSE MANAGER. H3 ¿ THE DEVICE RETURN IS UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

IT WAS REPORTED THAT, DURING THE PROCEDURE OF URETERAL STENT REMOVAL, A BANDER URETERAL DIVERSION STENT SET FRACTURED WHILE BEING REMOVED. THE PATIENT HAD A PREVIOUSLY PLACED URETERAL STENT, LEAVING A RETAINED FRAGMENT STENT WITHIN THE URINARY TRACT. THE RETAINED FRAGMENT COULD NOT BE RETRIEVED USING STANDARD CYSTOSCOPIC TECHNIQUES. AS A RESULT OF THIS DEVICE FAILURE, THE PATIENT WILL REQUIRE AN ADDITIONAL OPERATIVE INTERVENTION. A PERCUTANEOUS NEPHROLITHOTOMY (PCNL)-TYPE PROCEDURE WITH PERCUTANEOUS RENAL ACCESS WILL BE NECESSARY TO RETRIEVE THE RETAINED STENT FRAGMENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.