BRAVO

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: FGS-0635, FGS-0635 CF DELIVERY DEV CAPS BRAVO X5 (LOT#68490F). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ESOPHAGOGASTRODUODENOSCOPY, TWO CAPSULES WERE PLACED IN THE SAME PATIENT AND BOTH ATTEMPTS WERE FAILED TO ATTACH. THE FIRST CAPSULE WAS PLACED AS NORMAL AND EASY, AND AFTER THE BITE BLOCK WAS REMOVED THE DEPLOYED CAPSULE WAS FOUND IN THE PATIENT¿S MOUTH BY THE BITE BLOCK, INDICATING IT DID NOT REMAIN ATTACHED TO THE ESOPHAGUS; THE CAPSULE WAS RETRIEVED. A SECOND CAPSULE WAS PLACED, AND ON ENDOSCOPIC REVIEW WITH THE ESOPHAGOGASTRODUODENOSCOPY SCOPE THE CAPSULE HAVE FAILED TO SUCTION INTO PLACE IN THE ESOPHAGUS DESPITE SUCTION BEING SET AT THE INSTRUCTED LEVEL AND HELD FOR 30 SECONDS. THE SECOND CAPSULE WAS LOCATED IN THE PATIENT'S ESOPHAGUS. THERE WAS NO KINK IN THE WIRE WAS OBSERVED, AND NOTHING UNUSUAL ABOUT THE PATIENT OR PROCEDURE WAS REPORTED. THERE WAS NO PATIENT OR USER HARM.