AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

Additional Manufacturer Narrative

ON 12/16/2025 NTI WAS MADE AWARE OF AN ALLEGED EVENT IN WHICH A "PHYSICIAN AIMED EHL AT THE STONE, IT BROKE THE STONE BUT CAME IN CONTACT WITH THE CYSTIC DUCT CAUSING A BLEED". NTI REQUESTED ADDITIONAL INFORMATION ABOUT THE PROBE USED BUT NO FURTHER INFORMATION WAS AVALIABLE FROM THE CUSTOMER. NOR-(B)(4) REV T. WAS REVIEWED. RISK ID 4.8(A) THE RISK ANALYSIS CONSIDERS THE RISK OF BLEEDING AND CLINICAL EVALUATION (NOR-(B)(4) REV H) DETERMINES THE BENEFITS OF LITHOTRIPSY OUTWEIGH THE RISKS. THE INSTRUCTIONS FOR USE (NOR-(B)(4) REV C) HAS A WARNING WHICH STATES "DO NOT PRESS THE DISTAL TIP OF THE PROBE AGAINST TISSUE. TISSUE DAMAGE, INCLUDING PERFORATION OR THERMAL INJURY CAN RESULT." A SECONDARY WARNING IS ALSO LISTED, "IMPROPER USE OF THE EHL PROBE COULD RESULT IN VESSEL PERFORATION FOLLOWED BY BLEEDING AND POSSIBLE INFECTION. OTHER COMPLICATIONS SUCH AS VESSEL STRICTURES RESULTING FROM EDEMA AND OCCLUSIONS CREATED BY STONE DEBRIS ARE ALSO POTENTIAL COMPLICATIONS OF EHL." AS THE SINGLE USE DEVICE WAS NOT RETURNED, IT IS HARD TO DETERMINE WHAT LED TO THE PERFERATION, HOWEVER, BASED ON THE CUSTOMER DESCRIPTION, IT IS POSSIBLE THE PROBE TIP MADE CONTACT WITH TISSUE RESULTING IN INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PROLONGED INJURY, OR ADDITIONAL HOSPITAL INTERVENTION. IN THE PAST THREE YEARS, NTI HAS IDENTIFIED ONE OTHER PERFORATION/ TISSUE INJURY. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

ON (B)(6) 2025 NTI RECIEVED A COMPLAINT WHERE THE CUSTOMER REPORTED "PHYSICIAN AIMED EHL AT THE STONE, IT BROKE THE STONE BUT CAME IN CONTACT WITH THE CYSTIC DUCT CAUSING A BLEED." THE DEVICE WAS NOT RETURNED TO NTI FOR FURTHER EVALUATION.