BRAVO

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: FGS-0635, FGS-0635 CF DELIVERY DEV CAPS BRAVO X5 (LOT#67846F) 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. VISUAL INSPECTION OF THE DELIVERY DEVICE FOUND NO NOTABLE CONDITIONS. A COMPREHENSIVE EXAMINATION COULD NOT BE PERFORMED, BECAUSE THE RETURNED SAMPLE WAS NOT RECEIVED IN A STATE THAT ALLOWED FULL FUNCTIONAL OR VISUAL ASSESSMENT. IT WAS REPORTED THAT THE BRAVO CAPSULE FAILED TO ATTACH TO THE PATIENT'S ESOPHAGUS. 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. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT THE FIRST CAPSULE FAILED TO ATTACH TO THE PATIENT'S ESOPHAGUS. WHEN THE PHYSICIAN WENT DOWN TO CONFIRM PLACEMENT, IT WAS NOT ATTACHED TO THE ESOPHAGEAL WALL AND WAS NOT LOCATED IN THE STOMACH BUT WAS FOUND IN THE HYPOPHARYNX. THE PATIENT WAS EMERGENTLY INTUBATED TO PROTECT THE AIRWAY AND PREVENT POSSIBLE FOREIGN BODY ASPIRATION. DURING INTUBATION, THE CAPSULE WAS RETRIEVED BY ANESTHESIA USING HAND. A SECOND CAPSULE WAS PLACED ON THE SAME PROCEDURE AND IT STILL DID NOT ATTACH TO THE ESOPHAGEAL WALL. THE SECOND CAPSULE WAS FOUND IN THE ORAL PHARYNX AND WAS RETRIEVED WITH A ROTH NET. DUE TO TWO UNSUCCESSFUL DEPLOYMENT, THE CAPSULE PLACEMENT WAS ABORTED. THE PATIENT HAD SORE THROAT AND COUGH. NO LUBRICANT WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.