ESOFLIP

Additional Manufacturer Narrative

H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT THREE PHOTOS WERE AVAILABLE FOR EVALUATION. INSPECTION OF THE IMAGES NOTED BLACK PARTICULATE MATTER SUSPENDED IN THE SALINE SOLUTION. BIOLOGICAL CONTAMINATION HAS BEEN IDENTIFIED IN PRIOR SYRINGES CONTAINING PARTICULATE CONTAMINATION. IT WAS REPORTED THAT A FOREIGN OBJECT WAS FOUND IN THE PACKAGE OR PRODUCT. THE REPORTED ISSUE WAS CONFIRMED. 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 SHORTLY BEFORE THE EXAMINATION, THE CATHETER WAS FOUND TO BE CONTAMINATED AS IT HAD UNIDENTIFIABLE PARTICLES FLOATING IN THE LIQUID. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S PHOTOGRAPHIC EVALUATION OF THREE IMAGES PROVIDED BY THE COSTUMER FOUND BLACK PARTICULATE MATTER SUSPENDED IN THE SALINE SOLUTION. BIOLOGICAL CONTAMINATION HAS BEEN IDENTIFIED IN PRIOR SYRINGES CONTAINING PARTICULATE CONTAMINATION.