Pt with uretic stone. Uretic stent inserted antegradely in 2000 prior to lithotripsy. Stent would normally have been removed by urologist via cystoscopy post lithotripsy. Radiopaque marker band on proximal end of stent became detached and was loose in renal collecting system. Required surgical percutaneous nephrolithotomy procedure under general anesthetic to remove loose fragment of stent which would otherwise have formed focus for further stone formation in kidney.

This reported occurrence cannot be thoroughly investigated, at this time, due to the product not being returned to co's facility. Co does anticipate the return of the product, when it does become available for evaluation further info will be forwarded.

Received the stent with an unidentified dark substance on one side and extending approx. 16 1/2cm down the stent. The band and an unidentified crystalized substance were received in a vial with a clear liquid. Under microscopic view at the location of where the band had been placed on the stent some adhesive was noted, approx. 100 degrees around the tube no adhesive was found. In viewing the band the outside of the band was covered with adhesive and on the edges, small amount of adhesive was noted on the inside diameter of the band. Most likely, inadequate amount of adhesive has caused the band to become separated from the stent. Specifications were noted to be clear. Corrective/preventative action has been performed and training. Add'l testing has been performed resulting in a change the size of the radiopaque band for a more secure fit.