INFINITY ERCP SAMPLING DEVICE

Additional Manufacturer Narrative

THE FLUOROSCOPIC MARKER IS A RADIOPAQUE BAND SITUATED WITHIN THE GUIDEWIRE LUMEN NEAR THE DISTAL END OF THE DEVICE. THE HANDLE ASSEMBLY, CONTROL CABLE, AND CATHETER WERE DISCARDED BY THE USER FACILITY. THE DISTAL PORTION OF THE DEVICE WAS VISUALLY EXAMINED; HOWEVER, A FULL INVESTIGATION COULD NOT BE COMPLETED WITH THE PARTIAL DEVICE. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING STATEMENTS: "DO NOT FORCE THE BRUSH THROUGH THE ENDOSCOPE'S CHANNEL. REDUCE ANGULATION OF THE SCOPE IF RESISTANCE IS MET. PRIOR TO THE PROCEDURE, ACTUATE THE HANDLE SEVERAL TIMES TO BE SURE THE BRUSH FUNCTIONS PROPERLY. IF THE UNIT DOES NOT FUNCTION PROPERLY, OR THERE IS EVIDENCE OF DAMAGE (E.G., BENT BRUSH, BENT BRUSH STEM, KINKED CATHETER), DO NOT USE THIS PRODUCT AND CONTACT YOUR LOCAL PRODUCT SPECIALIST. WHEN USING A GUIDEWIRE, IRRIGATE THE GUIDEWIRE LUMEN OF THE CATHETER WITH STERILE WATER/SALINE." THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THE DEVICES WERE MANUFACTURED TO SPECIFICATION. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. A REVIEW OF PAST COMPLAINTS CONFIRMED THIS EVENT TO BE ISOLATED. US ENDOSCOPY HAS OFFERED IN-SERVICE TRAINING ON THE USE OF THE DEVICE; HOWEVER, THE USER FACILITY DECLINED. THERE HAVE BEEN NO FURTHER ISSUES REPORTED.

Description of Event or Problem

REFERENCE USER FACILITY MEDWATCH REPORT #5085400. THE USER FACILITY REPORTED THAT FOLLOWING A SAMPLING PROCEDURE, THE FLUOROSCOPIC MARKER FROM THE INFINITY SAMPLING DEVICE WAS DETECTED IN THE BILIARY DUCT. INTERVENTION WAS REQUIRED TO RETRIEVE THE MARKER.