BRAVO

Additional Manufacturer Narrative

H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE CAPSULE AND DELIVERY SYSTEM WERE RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THE HANDLE WAS SEPARATED FROM THE REST OF THE DELIVERY DEVICE. IT WAS REPORTED THAT THE BRAVO CAPSULE FAILED TO DETACH FROM THE DELIVERY SYSTEM DURING USE. THE REPORTED ISSUE WAS 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 PATIENT'S ESOPHAGUS AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM UPON REMOVAL. THE PHYSICIAN HAD TO PERFORM AN EMERGENCY HANDLE BREAK PROCEDURE TO RELEASE THE CAPSULE FROM THE DELIVERY SYSTEM. ANOTHER CAPSULE WAS USED AND IT WAS ABLE TO ATTACH SUCCESSFULLY. THERE WAS NO PATIENT AND USER HARM, AND NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE.