PERCUFLEX

Description of Event or Problem

IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED IN A RETROGRADE INTRARENAL SURGERY PROCEDURE IN THE KIDNEY. DURING INSERTION, IT WAS NOTICED THAT THE STENT FAILED TO GLIDE OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT BUCKLED MATERIAL.

Additional Manufacturer Narrative

BLOCK E1: (B)(6). 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 URETERAL STENT UNDERWENT A THOROUGH ANALYSIS. VISUAL ANALYSIS IDENTIFIED THAT THE BLADDER COIL WAS BUCKLED. FUNCTIONAL EVALUATION REVEALED THAT A SENSOR WIRE OF 0.038 WAS INSERTED INTO THE STENT TO EVALUATE IF SOME RESISTANCE WAS FELT INSIDE THE DEVICE, HOWEVER, SOME RESISTANCE WAS FELT DURING THE ANALYSIS PERFORMED AND THE GUIDEWIRE WAS NOT ABLE TO FULLY PASS THROUGH THE STENT DUE TO THE STENT BLADDER COIL WAS BUCKLED. THE POSITIONER WAS ALSO RETURNED FOR ANALYSIS. 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 COIL 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, IT IS POSSIBLE TO CONCLUDE THAT THE ISSUE COULD BE CAUSED BY OPERATIONAL FACTORS. IF THE POSITIONER WAS 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. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE.