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 THAT THE PROBISCUS AND THE BOOT WERE NOT PROPERLY ADHERED TOGETHER. THE PUSH WIRE HAD BEEN PUSHED THROUGH THE SIDE OF THE DUAL LUMEN. IT WAS REPORTED THAT THE BRAVO CAPSULE FAILED TO DETACH FROM THE 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 THE CAPSULE FAILED TO DETACH FROM THE DELIVERY DEVICE. THE PHYSICIAN HAD TO PERFORM THE EMERGENCY PROTOCOL TO RELEASE THE CAPSULE FROM THE DELIVERY DEVICE. THE CAPSULE WAS STILL ATTACHED TO THE DELIVERY DEVICE WHEN IT WAS REMOVED FROM THE PATIENT. A SECOND CAPSULE WAS USED AND IT ATTACHED SUCCESSFULLY. THERE WAS NO PATIENT OR USER HARM. LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.