PERCUFLEX? PLUS

Description of Event or Problem

IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN AN INDWELLING FLEXIBLE URETEROSCOPE FOR RENAL CALCULI PROCEDURE. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT COULD NOT BE ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WAS NO PATIENT COMPLICATIONS REPORTED.

Additional Manufacturer Narrative

BLOCK H6: DEVICE CODE A040601 CAPTURES THE REPORTABLE INVESTIGATION RESULT OF STENT BUCKLED MATERIAL INSIDE THE PATIENT. BLOCK H11: INVESTIGATION ANALYSIS: UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS PERCUFLEX PLUS URETERAL STENT UNDERWENT A THOROUGH ANALYSIS. VISUAL ANALYSIS IDENTIFIED THAT THE SHAFT AND THE COIL WERE BUCKLED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF STENT/DELIVERY SYSTEM DIFFICULT TO ADVANCE AND STENT BUCKLED/ACCORDION WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFITS FOR THE PRODUCT. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE REPORTED ALLEGATION OF STENT DIFFICULT TO ADVANCE COULD BE CONFIRMED. IT IS POSSIBLE TO CONCLUDE THAT THIS ISSUE COULD BE CAUSED BY OPERATIONAL FACTORS. IF THE POSITIONER IS ADVANCED WITH EXCESS FORCE OVER THE GUIDEWIRE THE STENT COULD GET BUCKLED/ACCORDIONED RESULTING IN A DIFFICULTY/UNABLE TO ADVANCE THE STENT TO THE TARGET SITE. A CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION.