ESOFLIP

Description of Event or Problem

ACCORDING TO THE REPORTER, THE CATHETER FAILED THE PRE-USE CHECK WITH ERROR REPLACE CATHETER. THERE WAS NO PATIENT INVOLVED.

Additional Manufacturer Narrative

PRODUCT ANALYSIS # (B)(4): THIS REPORT IS BASED ON INFORMATION PROVIDED BY RETURNED PRODUCT ANALYSIS (RPA) LAB INVESTIGATION PERSONNEL. RPA LAB RECEIVED ONE ES-330 OPENED BY THE ACCOUNT WITH THE APPROPRIATE PACKAGING. VISUAL INSPECTION: 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. EVALUATION: THE BALLOON WAS MANUALLY INFLATED AND THERE WERE NO OBSERVED LEAKS. THE CATHETER PASSED THE CONTINUITY TEST BETWEEN THE LANDING AND WELDING PADS. THE THERMISTOR RESISTANCE VALUES WERE FOUND TO BE WITHIN AN ACCEPTABLE RANGE. THE PRESSURE IMPEDANCE VALUES WERE FOUND TO BE WITHIN ACCEPTABLE RANGES. THE RETURNED SALINE WAS USED FOR FUNCTIONAL TESTING. THE CATHETER FAILED THE PRE-USE CHECK; THE DEST VALUES WERE INVALID. THE SALINE WAS REPLACED WITH KNOWN GOOD SALINE AND THE CATHETER WAS SUBJECTED TO THE PRE-USE CHECK AGAIN. THE CATHETER PASSED THE PRE-USE CHECK, AND THE PRESSURE SENSOR, D-EST, AND THERMISTOR READINGS WERE ALL FOUND TO BE WITHIN SPECIFICATIONS. THE BALLOON TEMPERATURE READING AND CATHETER CURRENT WERE FOUND TO HAVE ACCEPTABLE VALUES. THE CONDUCTIVITY OF THE RETURNED SALINE WAS MEASURED AND THE SALINE CONDUCTIVITY WAS FOUND TO BE OUT OF SPECIFICATION. THIS PRODUCT WAS FORWARDED TO ENGINEERING FOR FURTHER EVALUATION OF FAILED PRECHECK AND SALINE CONDUCTIVITY. 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.