ENDOFLIP

Additional Manufacturer Narrative

H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. INSPECTION OF THE CATHETER NOTED BLACK PARTICULATE MATTER SUSPENDED IN THE SALINE SOLUTION. BIOLOGICAL CONTAMINATION HAS BEEN IDENTIFIED IN PRIOR SYRINGES CONTAINING PARTICULATE CONTAMINATION. THE MOST LIKELY CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. INTERNAL PROCESS IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS ISSUE. 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 THE CATHETER HAD FAILED SENSORS. PRECHECK WAS TRIED MORE THAN ONCE. THERE WAS NO PATIENT OR USER HARM. FUNCTIONAL TESTING OF THE RETURNED CATHETER CONFIRMED A MANUFACTURING FAULT. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY.