ESOFLIP

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: ES-330, CATHETER ES-330 30MM ESO DILATION (LOT#24F0465JZ); ES-330, CATHETER ES-330 30MM ESO DILATION (LOT#24F0465JZ); ES-330, CATHETER ES-330 30MM ESO DILATION (LOT#24F0465JZ) H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE TRANSPORTATION SHEATH WAS ATTACHED TO THE BALLOON. THE ELECTROSTATIC DISCHARGE (ESD) COVER WAS ATTACHED TO THE PRINTED CIRCUIT BOARD (PCB). THE BALLOON WAS NOT WET. THE BALLOON ELECTRODES WERE NOT CORRODED. THERE WAS NO OBSERVED CORROSION ON THE PCB PADS. THE SYRINGE WAS NOT ATTACHED TO THE CATHETER. THERE WERE NO KINKS ON THE CATHETER LINE. SALINE WAS TESTED AND THE SALINE WAS OUT OF SPECIFICATION. THIS WILL CAUSE THE D-EST TO VALUES TO BE OUT OF SPECIFICATION. THE CATHETER PASSED FUNCTIONAL TESTING WITH LAB SALINE. IT WAS REPORTED THAT THE CATHETERS FAILED PRE-USE CHECK. THE MOST LIKELY CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. 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, BOTH CATHETERS FAILED PRE-USE CHECK. THE CUSTOMER TRIED THE PRE-USE CHECK TWICE ON EACH CATHETER. ANOTHER CATHETER FROM ANOTHER LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE SALINE WAS OUT OF SPECIFICATION.