BRAVO

Additional Manufacturer Narrative

H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE CAPSULE WAS NOT RETURNED, BUT THE DELIVERY SYSTEM WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION OF THE DELIVERY DEVICE FOUND NO NOTABLE CONDITIONS. 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 DETACH FROM DELIVERY SYSTEM DURING USE. 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 A CAPSULE FAILED TO DETACH FROM THE DELIVERY SYSTEM. THE PHYSICIAN BROKE THE HANDLE TO REMOVE THE CAPSULE BUT IT REMAINED ATTACH TO THE DELIVERY DEVICE WHEN IT WAS REMOVED FROM THE PATIENT. THE VACUUM PUMP PRESSURE REPORTEDLY REACHED 550 MMHG PRIOR TO PLACEMENT USING MEDELA SUCTION, AND THE DEPLOYMENT DEVICE WAS REPORTEDLY INSERTED WITH THE CAPSULE FACING THE TONGUE WHILE THE ENTIRE DEVICE INCLUDING THE HANDLE WAS MAINTAINED IN THE HORIZONTAL PLANE. THERE WAS NO PATIENT OR USER HARM. NO LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.