BRAVO

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: FGS-0635, FGS-0635 CF DELIVERY DEV CAPS BRAVO X5 (LOT#68486F) H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DELIVERY SYSTEM WAS NOT RETURNED, BUT THE CAPSULE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION OF THE CAPSULE FOUND NO NOTABLE CONDITIONS. THE CAPSULE WAS RETUNED WITH A DEPLOYED NEEDLE. A COMPREHENSIVE EXAMINATION COULD NOT BE PERFORMED, BECAUSE THE RETURNED SAMPLE WAS NOT RECEIVED IN A STATE THAT ALLOWED FULL FUNCTIONAL OR VISUAL ASSESSMENT. IT WAS REPORTED THAT THE BRAVO CAPSULE FAILED TO ATTACH TO THE PATIENT'S ESOPHAGUS. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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 ESOPHAGUS. THE CAPSULE WAS THEN LOCATED IN THE ESOPHAGUS AND WAS RETRIEVED FROM THE BODY USING A SNARE. ANOTHER ATTEMPT WAS MADE TO PLACE A SECOND CAPSULE, BUT IT FAILED TO ATTACH. ENDOSCOPIC VERIFICATION OF CAPSULE PLACEMENT WAS PERFORMED. THE DEPLOYMENT DEVICE WAS INSERTED WITH THE CAPSULE FACING THE TONGUE AND WITH THE ENTIRE DEVICE INCLUDING THE HANDLE MAINTAINED IN THE HORIZONTAL PLANE, AND SUCTION WAS APPLIED USING A MEDELA PUMP WITH VACUUM PRESSURE REACHING 550 MMHG PRIOR TO PLACEMENT.