BARD® INLAY® VERSA FIT® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE

Description of Event or Problem

CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY STATED THAT IN CHARTS 3 AND 4, IN THE ONLINE SURVEY A DR. IN QUESTION: "DO YOU BELIEVE THE BENEFITS OF USING THE BARD/BECTON DICKINSON INLAY¿ AND INLAY VERSAFIT¿ URETERAL STENTS OUTWEIGH THE POTENTIAL RISKS (I.E. DO THE PROS OUTWEIGH THE CONS)?" SHE/HE ANSWERED "NO, THE BENEFITS OF USING THIS PRODUCT DO NOT OUTWEIGH THE POTENTIAL RISKS.¿ BECAUSE "WHILE THE PRODUCT OFFERS SEVERAL BENEFITS, THERE ARE SOME POTENTIAL RISKS THAT REQUIRE CONSIDERATION. THE RISKS INCLUDE DATA PRIVACY CONCERNS, LEARNING CURVE FOR NEW USERS, AND POTENTIAL INTEGRATION CHALLENGES WITH EXISTING SYSTEMS. ADDITIONALLY, THERE MAY BE COST-BENEFIT CONSIDERATIONS THAT NEED TO BE WEIGHED MORE CAREFULLY IN CERTAIN USE CASES. ", ALSO, IN CHARTS 3 AND 5 IN THE ONLINE SURVEY IN QUESTION: "WAS THE STENT SUCCESSFUL IN RELIEVING URETERAL OBSTRUCTION TO ALLOW FOR URINE " SHE/HE ANSWERED "NO¿ BECAUSE "TOO SMALL " IN BOTH CHARTS. IN CHART 5 IN THE ONLINE SURVEY A IN QUESTION: "DID THE GUIDEWIRE SUPPORT STENT PLACEMENT PROCEDURE? SHE/HE ANSWERED "NO¿ BECAUSE "DOESN'T FIT " THE CODE OF PRODUCT IS CHART 3- 777400 CHART 5- 776428.

Additional Manufacturer Narrative

INITIAL REPORTER PHONE NUMBER: (B)(6). 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.