SHILEY

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCTS: 126035 35FR RT BRONCO CATH PU CUFF X1, (LOT# 202401113X) 126037 37FR RT BRONCO CATH PU CUFF X1 (LOT# 202404285X) 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 CUFF THE FIRST HAD A CRACK AND THE SECOND DEVICE HAD A HOLE PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

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 THAT THE TRACHEAL CUFF HAS A LARGE VISIBLE TEAR. THE BRONCHIAL CUFF WAS SUCCESSFULLY INFLATED AS PER TEMPLATE IF001. THE TEAR, ON THE TRACHEAL CUFF WAS TOO LARGE TO MEASURE UNDER THE MICROVU APPROXIMATELY 3CM IN LENGTH. IT WAS REPORTED THAT THE CUFF OF THE FIRST TUBE HAD A CRACK. 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: VARIOUS BONY ANATOMICAL STRUCTURES (E.G. TEETH, TURBINATES) WITHIN THE INTUBATION ROUTES OR ANY INTUBATION TOOLS WITH SHARP SURFACES PRESENT A THREAT TO MAINTAINING CUFF INTEGRITY. CARE MUST BE TAKEN TO AVOID DAMAGING THE THIN-WALLED CUFFS DURING INTUBATION WHICH WOULD CREATE THE NEED TO SUBJECT THE PATIENT TO THE TRAUMA OF EXTUBATING AND RE-INTUBATION. 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.