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. A PHOTO WAS ALSO PROVIDED. VISUAL INSPECTION FOUND THE PLUNGER WAS UP WITH AN EXPOSED SPRING. THIS INDICATES THE PLUNGER BEING ROTATED DURING PLUNGER DEPRESSION. IT WAS REPORTED THAT THE CAPSULE FAILED TO DETACH FROM THE DELIVERY SYSTEM DURING USE. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: PRESS DOWN ON THE PLUNGER WITH A SWIFT AND SMOOTH MOTION TO ACTUATE THE DELIVERY DEVICE MECHANISM. PRESSING DOWN ON THE PLUNGER TOO SLOWLY MAY RESULT IN THE CAPSULE NOT PROPERLY ATTACHING TO THE PATIENT¿S ESOPHAGUS OR NOT DETACHING FROM THE DELIVERY DEVICE. DO NOT ROTATE THE PLUNGER WHILE DEPRESSING IT. 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 THEY HAD A CAPSULE WHICH FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS AND STILL ATTACHED TO THE DELIVERY SYSTEM UPON REMOVAL. THE DELIVERY DEVICE WAS REMOVED AND A NEW CAPSULE WAS USED. A SECOND PLACEMENT ATTEMPT WAS PERFORMED AND THE CAPSULE WAS SUCCESSFULLY ATTACHED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED. NO LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE. THERE WAS NO PATIENT OR USER HARM.