ESOFLIP

Description of Event or Problem

ACCORDING TO THE REPORTER, THE CATHETER HAD INACCURATE DATA READING. THE READINGS SAW ON THE SCREEN DID NOT MATCH THE EFFECT SEEN VISUALLY. BECAUSE OF THIS, AT 55ML OF INFLATION (OUT OF A MAXIMUM OF 70ML), PHYSICIAN DECIDED NOT TO PROCEED ANY FURTHER DUE TO LACK OF ACCURATE FEEDBACK CAUSING RISK FOR THE PATIENT. THERE WAS NO PATIENT AND USER HARM.

Additional Manufacturer Narrative

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.