UNKNOWN NEPHROURETEROSTOMY STENT

Description of Event or Problem

IT WAS REPORTED THAT AN UNKNOWN NEPHROURETEROSTOMY STENT SEPARATED DURING A REMOVAL PROCEDURE FOR AN UNKNOWN PATIENT. THE DEVICE WAS TO BE REMOVED FROM THE PATIENT AFTER BEING IN PLACE FOR SIX MONTHS. THE STENT WAS FOUND TO BE ENCRUSTED IN THE URETER, AND THE USER WAS UNABLE TO ADVANCE A WIRE THROUGH THE LUMEN. THE STENT THEN BROKE, WITH THE DISTAL PORTION OF THE DEVICE BEING LEFT IN THE PATIENT. THE PATIENT RECEIVED A REFERRAL TO ANOTHER FACILITY FOR RETRIEVAL OF THE SEPARATED DEVICE PORTION.

Additional Manufacturer Narrative

H3 - DEVICE EVALUATED BY MFG?: THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER 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 DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.