BRAVO

Description of Event or Problem

IT WAS REPORTED THAT THE CAPSULE FAILED ATTACHED TO PATIENT'S ESOPHAGUS AND FAILED TO DETACH FROM THE DELIVERY SYSTEM UPON REMOVAL. THE PHYSICIAN BROKE THE HANDLE DURING THE PROCEDURE BUT THE CAPSULE REMAINED ATTACHED TO THE DELIVERY DEVICE WHEN IT WAS REMOVED FROM THE PATIENT. THERE WERE NO VISIBLE TEARS AND/OR LACERATIONS CAUSED TO THE ESOPHAGUS. THE DEPLOYMENT DEVICE WAS INSERTED WITH THE CAPSULE FACING THE TONGUE AND MAINTAINED IN THE HORIZONTAL PLANE. VACUUM PUMP PRESSURE REPORTEDLY REACHED 550 MMHG USING MEDELA SUCTION. THERE WAS NO LUBRICANT USED TO FACILITATE THE DEVICE. THERE WAS NO PATIENT OR USER HARM.

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 NOTED THAT THE PLUNGER WAS BROKEN AND WAS NOT CONNECTED TO THE HANDLE. THE PLUNGER WAS ROTATED MORE THAN 1/8 OF TURN AND FAILED TO ATTACH THE CAPSULE TO THE ESOPHAGUS. IT WAS REPORTED THAT THE BRAVO 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: DO NOT ROTATE OR OTHERWISE FORCE THE PLUNGER BEYOND THE WHITE LINE ON THE BARREL. ROTATING OR FORCING THE PLUNGER BEYOND THIS MAY RESULT IN POSSIBLE DAMAGE TO THE DELIVERY DEVICE. THIS MAY ALSO INTERFERE WITH THE DETACHMENT OF THE CAPSULE FROM THE DELIVERY DEVICE, AND CAUSE POSSIBLE INJURY TO THE PATIENT. 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.