T-DOC AIR-CHARGED SINGLE SENSOR COUDE CATHETER

Additional Manufacturer Narrative

THIS INCIDENT DID NOT RESULT IN A SERIOUS INJURY OF THE PATIENT OR REQUIRE MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED TO THE FDA BASED ON A REVIEW OF THE RISK DOCUMENTATION FOR THE DEVICE WHICH IDENTIFIED THAT, WERE THIS MALFUNCTION TO OCCUR AGAIN, THERE IS THE POSSIBILITY THAT MEDICAL INTERVENTION MIGHT BE NECESSARY TO PREVENT SERIOUS INJURY. LABORIE IS STILL AWAITING ADDITIONAL INFORMATION FROM THE REPORTER RELATED TO THIS EVENT, AS WELL AS THE SUBJECT DEVICE TO BE RETURNED, IN ORDER FOR A MORE THOROUGH INVESTIGATION TO BE PERFORMED. ONCE LABORIE HAS OBTAINED FURTHER DETAILS ON THIS EVENT AND HAS BEEN ABLE TO REVIEW POTENTIAL ROOT CAUSES, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

Description of Event or Problem

A LABORIE URETHRAL CATHETER WAS USED IN A PATIENT IN FRANCE AS PART OF A URODYNAMICS STUDY. A METAL FILAMENT IN THE CATHETER WAS PROTRUDING AND RESULTED IN A LESION OF THE PATIENT'S URETHRA.