SINGLE USE 3-LUMEN EXTRACTION BALLOON V

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: WHITE FOREIGN OBJECTS, BELIEVED TO BE CONTRAST MEDIUM, WERE FOUND INSIDE THE BALLOON. A WHITE FOREIGN SUBSTANCE, BELIEVED TO BE CONTRAST DYE, WAS ALSO FOUND ADHERING TO THE STOPCOCK. THEREFORE, THE REPORTED EVENT IS INFERRED TO HAVE OCCURRED THROUGH THE FOLLOWING MECHANISM. 1) DURING USE, ANYTHING OTHER THAN AIR WAS INJECTED INTO THE AIR-FEEDING PORT. 2) THE INJECTED SUBSTANCES WOULD BLOCK THE LUMEN LEADING TO THE BALLOON. 3) THE BALLOON DID NOT DEFLATE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED THE SINGLE USE EXTRACTION BALLOON WAS UNABLE TO DEFLATE DURING A BILE DUCT STONE EXTRACTION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.