SHILEY

Additional Manufacturer Narrative

CONCOMITANT PRODUCT: 126037, 126037 37FR RT BRONCO CATH PU CUFF X1. (LOT# 202206373X). 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 A DOUBLE-LUMEN ENDOBRONCHIAL TUBE WAS IMPLANTED BEFORE THE OPERATION, AND THE CUFF WAS FOUND TO BE LEAKING AIR. THE MEDICAL STAFF REPLACED THE TUBE A SECOND TIME WITH NO HARM CAUSED TO THE PATIENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE AND A PHOTO WERE AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED A SURFACE SLIT THAT MEASURES 1.6MM IN LENGTH. AN ATTEMPT WAS MADE TO INFLATE THE CUFFS AS PER THE PARAMETERS OUTLINED IN IF001. THE BRONCHIAL CUFF INFLATED SUCCESSFULLY WHILE THE TRACHEAL CUFF DEFLATED RAPIDLY. IT WAS REPORTED THAT A DOUBLE-LUMEN ENDOBRONCHIAL TUBE WAS IMPLANTED BEFORE THE OPERATION, AND THE CUFF WAS FOUND TO BE LEAKING AIR. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: SYRINGES, THREE-WAY STOPCOCKS OR OTHER LUER TIP DEVICES SHOULD NOT BE LEFT INSERTED IN THE INFLATION VALVES FOR EXTENDED PERIODS OF TIME. 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.