BRAVO

Description of Event or Problem

IT WAS REPORTED THAT THEY HAD A CAPSULE WHICH FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS AND FOUND IN THE PATIENT¿S ESOPHAGUS. A SNARE WAS USED TO RETRIEVED THE CAPSULE. A SECOND CAPSULE WAS ATTEMPTED BUT ALSO FAILED TO ATTACH. NO LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: FGS-0635, FGS-0635 CF DELIVERY DEV CAPS BRAVO X5 (LOT#UNKNOWN). 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. THE VISUAL INSPECTION OF THE DELIVERY DEVICE 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 ATTACH TO THE PATIENT'S ESOPHAGUS. 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.