UROMAX ULTRA

Additional Manufacturer Narrative

BLOCK H6: DEVICE CODE A040601 CAPTURES THE REPORTABLE INVESTIGATION RESULT OF CATHETER KINKED. BLOCK H11: INVESTIGATION RESULTS. THE RETURNED UROMAX ULTRA DEVICE WAS ANALYZED AND A VISUAL EXAMINATION NOTED THAT THE BALLOON HAD BEEN INFLATED. IT WAS ALSO NOTED THAT THE BALLOON MATERIAL AND MARKERBANDS FOUND NO PROBLEMS. ADDITIONALLY, THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE DEVICE WAS SUBJECTED TO POSITIVE PRESSURE. THE SHAFT OF THE DEVICE WAS KINKED ON TWO LOCATIONS INSIDE THE BALLOON. NO OTHER PROBLEMS WERE FOUND WITH THE TIP OF THE DEVICE. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT WAS CONFIRMED. THE REPORTED PROBLEM IS MOST LIKELY DUE TO HANDLING DURING PREPARATION FOR THE PROCEDURE WHICH RESULTS TO THE DEVICE KINKED. THEREFORE, AN INVESTIGATION CONCLUSION CODE OF UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT WAS ASSIGNED TO THIS INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS TO USE DURING A URETEROSCOPY (URS) PROCEDURE. REPORTEDLY, IT WAS FOUND THAT THE BALLOON SECTION WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT SHAFT WAS KINKED ON TWO LOCATIONS INSIDE THE BALLOON.