ESOFLIP

Additional Manufacturer Narrative

H3 - EVALUATION SUMMARY: FUNCTIONAL TESTING OF THE RETURN DEVICE CONFIRMED A MANUFACTURING FAULT. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY. A PROCESS IMPROVEMENT HAS BEEN INITIATED TO PREVENT THIS CONDITION FROM RECURRING 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

ACCORDING TO THE REPORTER, A BOX OF 5 CATHETERS TURNED IN DUE TO RECALL. THE ABNORMAL D-EST VALUES WAS CONDUCTED, AND IT WAS FOUND THAT IF THE MIXING OF SALINE SOLUTION DURING THE MANUFACTURING PROCESS IS NOT HOMOGENEOUS, THE SALINE SOLUTION WILL GIVE A CONDUCTIVITY OUT OF RANGE. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

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 NOT ATTACHED TO THE BALLOON. THE ELECTROSTATIC DISCHARGE (ESD) COVER WAS NOT 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. FUNCTIONALLY, THE BALLOON WAS MANUALLY INFLATED AND THERE WERE NO OBSERVED LEAKS. THE CATHETER PASSED FAILED PRE-USE CHECK, D EST VALUES WERE FOUND TO BE OUT OF SPECIFICATION. SALINE WAS TESTED AND THE SALINE CONDUCTIVITY WAS SIGNIFICANTLY OUT OF SPECIFICATION CAUSING THE CATHETER TO FAIL FUNCTIONAL TESTING. IT WAS REPORTED THAT IF THE MIXING OF SALINE SOLUTION DURING THE MANUFACTURING PROCESS IS NOT HOMOGENEOUS, THE SALINE SOLUTION WILL GIVE A CONDUCTIVITY OUT OF RANGE. THE REPORTED ISSUE WAS CONFIRMED. 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.

Additional Manufacturer Narrative

EVALUATION SUMMARY: FUNCTIONAL TESTING OF THE RETURN DEVICE CONFIRMED A MANUFACTURING FAULT. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY. A PROCESS IMPROVEMENT HAS BEEN INITIATED TO PREVENT THIS CONDITION FROM RECURRING. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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

ACCORDING TO THE REPORTER, A BOX OF 5 CATHETERS TURNED IN DUE TO RECALL. THERE WAS NO PATIENT INVOLVED.