UNKNOWN URETERAL STENTS

Description of Event or Problem

CRITICAL CARE NURSE REPORTED IN THE ONLINE SURVEY THAT THE PATIENT EXPERIENCED ADVERSE EVENTS URETERAL REFLUX ASSOCIATED WITH THE DEVICE INLAY OPTIMA¿ MULTI-LENGTH URETERAL STENT WITHOUT GUIDEWIRE. THAT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.

Additional Manufacturer Narrative

THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE PRODUCT CATALOG NUMBER FOR THIS DEVICE IS UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. CORRECTIONS MADE TO TAB(S) F AND G. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE CRITICAL CARE NURSE REPORTED IN THE ONLINE SURVEY THAT THE PATIENT EXPERIENCED ADVERSE EVENTS. URETERAL REFLUX ASSOCIATED WITH THE DEVICE INLAY OPTIMA MULTI-LENGTH URETERAL STENT WITHOUT GUIDEWIRE. THAT DID NOT RESULTED IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.