BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE

Description of Event or Problem

IT WAS REPORTED THAT THE PHYSICIAN OPENED THE STERILE PACKAGING OF THE URETERAL STENT, REMOVED THE STENT, CUT THE SUTURE AT THE TAIL END, AND ACTIVATED THE COATING WITH STERILE WATER. DURING THE PROCEDURE, A DEFECT WAS DISCOVERED IN THE PIG-TAIL AT THE PROXIMAL END OF THE STENT, RENDERING IT UNUSABLE.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.