BRAVO

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: FGS-0635, FGS-0635 CF DELIVERY DEV CAPS BRAVO X5 (LOT#66423F) 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 THE CAPSULE FAILED TO ATTACH TO THE PATIENT ESOPHAGUS AND REMAINED ATTACH TO THE DELIVERY DEVICE UPON REMOVAL. DURING FINAL PUSH AND RELEASE OF THE CAPSULE, THE TROCAR NEEDLE ON THE DELIVERY DEVICE PUSHED THE ESOPHAGEAL MUCOSA WHEN ATTEMPTING TO DEPLOY. THE CAPSULE DID NOT DEPLOY, AND THE ESOPHAGUS HAD VISIBLE BLOOD/TRAUMA. ANOTHER CAPSULE WAS USED BUT STILL FAILED TO ATTACH TO THE PATIENT ESOPHAGUS AND REMAINED ATTACHED TO THE DELIVERY DEVICE UPON REMOVAL. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE. THE PATIENT WAS NOT INJURED.