SHILEY

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. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT DURING USE OF A DOUBLE-LUMEN TUBE, A FOREIGN OBJECT (BLUE FIBER) WAS DETECTED IN THE BRONCHIAL LUMEN AFTER INTUBATION AND DURING FIBEROPTIC POSITION CONTROL. AN ATTEMPT WAS MADE TO RETRIEVE THE FIBER USING SUCTION, BUT IT COULD NOT BE DETECTED IN THE SUCTION SYSTEM, THE TUBE, OR THE PATIENT AFTER THE RETRIEVAL ATTEMPT. A FIBEROPTIC INSPECTION OF THE PLASTIC COMPONENTS AND TUBES SHOWED NO EVIDENCE OF THE FOREIGN OBJECT, AND A VISUAL INSPECTION REVEALED THAT BOTH CUFFS APPEARED TO BE INTACT AND LEAK-FREE. THE DOUBLE-LUMEN TUBE WAS REPLACED BEFORE THE SURGICAL PROCEDURE BEGAN THROUGH A TROUBLE-FREE REINTUBATION. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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

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 DURING USE OF A DOUBLE-LUMEN TUBE, A FOREIGN OBJECT (BLUE FIBER) WAS DETECTED IN THE BRONCHIAL LUMEN AFTER INTUBATION AND DURING FIBEROPTIC POSITION CONTROL. AN ATTEMPT WAS MADE TO RETRIEVE THE FIBER USING SUCTION, BUT IT COULD NOT BE DETECTED IN THE SUCTION SYSTEM, THE TUBE, OR THE PATIENT AFTER THE RETRIEVAL ATTEMPT. A FIBEROPTIC INSPECTION OF THE PLASTIC COMPONENTS AND TUBES SHOWED NO EVIDENCE OF THE FOREIGN OBJECT, AND A VISUAL INSPECTION REVEALED THAT BOTH CUFFS APPEARED TO BE INTACT AND LEAK-FREE. THE DOUBLE-LUMEN TUBE WAS REPLACED BEFORE THE SURGICAL PROCEDURE BEGAN THROUGH A TROUBLE-FREE REINTUBATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.