Complications of stone baskets: 14-year review of the manufacturer and user facility device experience database

Abstract

Purpose: We categorized trends in failure of the stone baskets as reported in the United States Food and Drug Administration Manufacturer and User Facility Device Experience database.

Materials and methods: We queried the online database using the code for stone baskets (FFL) from January 1996 to December 2009. Variables extracted were the type of basket, malfunction and treatment, and patient outcome.

Results: We identified 556 adverse events related to stone baskets. The device configuration was tipped in 48% of cases, tipless in 36%, forceps in 8% and the Stone Cone™ in 8%. Malfunction type included detachment of a portion of the basket in 49% of cases, breakage without detachment in 39% and inability to withdraw the basket in 12%. Compared to the early period studied (1996 to 2004) there was a 3-fold increase in adverse events from 2005 to 2007 and a 6-fold increase from 2008 to 2009. Of adverse events 79% and 11% were managed by endoscopy and open surgery, respectively. Of the patients 42 experienced serious complications requiring major surgery, including ureteral reconstruction in 7, reimplantation in 4 and nephrectomy in 7.

Conclusions: With the increased use of stone baskets in the upper collecting system the number of adverse events has increased. Urologists should remain vigilant to prevent, recognize and manage these events.