EVEREST INFLATION DEVICE 30ATM

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.

Description of Event or Problem

IT WAS REPORTED THAT ONE EVEREST INFLATION DEVICE WAS NOT WORKING PROPERLY DURING A PROCEDURE. THE DEVICE EXPERIENCED INFLATION DIFFICULTIES IN THE PATIENT AND WAS NOT ABLE TO INFLATE AND DEFLATE PROPERLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: IT WAS REPORTED THAT ONE EVEREST INFLATION DEVICE WAS NOT WORKING PROPERLY DURING A PROCEDURE WHEN NO PROPERLY INFLATED OR DEFLATED. THE NEEDLE ON THE GAUGE MOVE SLIGHTLY WHEN PRESSURE WAS APPLIED. THE NEEDLE RETURNED TO ZERO WHEN DEFLATION WAS ATTEMPTED. THE EVEREST WAS CONNECTED TO A NON-MEDTRONIC BALLOON WHEN THE EVENT OCCUR. THE DEVICE THAT WAS CONNECTED TO THE EVEREST WAS IN THE PATIENT WHEN THE ISSUE OCCUR. THE STOPCOCK WAS NOT CONNECTED BETWEEN THE EVEREST DEVICE AND THE OTHER DEVICE. LITTLE RESISTANCE WAS NOTED WHILE ADVANCING THE NON-MEDTRONIC BALLOON TO THE LESION WHILE CONNECTED TO THE EVEREST DEVICE. ANOTHER EVEREST INFLATION DEVICE WAS USED WITH NO ISSUES. PRODUCT ANALYSIS: ONE EVEREST INFLATION DEVICE WAS RECEIVED FOR ANALYSIS. NO DAMAGE NOTED TO THE SYRINGE BODY, TUBE JOINTS OR MANOMETER HOUSING. AS RECEIVED THE GAUGE NEEDLE WAS AT APPROX. 0ATM. USING AN IN-HOUSE STOPCOCK, THE DEVICE WAS PRESSURIZED WITH WATER. THE GAUGE NEEDLE MOVED STEADILY TO 30 ATM AND THE DEVICE HELD PRESSURE FOR A MINIMUM OF THREE MINUTES (WITH MAX 10% LOSS), MEETING SPECIFICATION. UPON RELEASE OF PRESSURE THE GAUGE NEEDLE DROPPED TO APPROX. 0ATM. WHEN VACUUM WAS APPLIED, THE GAUGE NEEDLE MOVED INTO/TOWARDS THE RED ¿VAC¿ READING. THE DEVICE WAS ABLE TO PRESSURIZE AND MAINTAIN PRESSURE PER SPECIFICATION. ANNEX B CODE ANNEX C CODE ANNEX D CODE 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

ADDITIONAL INFORMATION: - ANNEX D CODE ADDED 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.