TRIA? SOFT

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0414 CAPTURES THE REPORTABLE EVENT OF STENT TORN.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE, A TRIA URETERAL STENT WAS USED, AND NOTICED THAT THE CATHETER CUTS ITSELF OFF. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0414 CAPTURES THE REPORTABLE EVENT OF STENT TORN. BLOCK H11: THE RETURNED TRIA SOFT URETERAL STENT WITH SUTURE AND POSITIONER WAS ANALYZED. DURING THE INSPECTION WAS FOUND STENT BLADDER COIL DETACHED, WHICH DID NOT CONFIRM THE REPORTED EVENT OF STENT TORN. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, IT IS POSSIBLE TO CONCLUDE THAT THIS PROBLEM COULD BE CAUSED BY OPERATIONAL FACTORS. 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 TORN MATERIAL AND STENT COIL DETACHED/SEPARATED" WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFITS FOR THE PRODUCT. THEREFORE, AN INVESTIGATION CONCLUSION CODE OFADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION. ADDITIONAL INFORMATION FOR FIELD A2: AGE, A3A SEX, A3B GENDER, A4 WEIGHT, A4 MEASUREMENT OF WEIGHT, E1: INITIAL REPORTER TITLE, INITIAL REPORTER FIRST AND LAST NAME; AND FOR BLOCK E3: OCCUPATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE, A TRIA URETERAL STENT WAS USED, AND NOTICED THAT THE CATHETER CUTS ITSELF OFF. NO PATIENT COMPLICATIONS WERE REPORTED.