SHILEY

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, THE CUFF OF THE BRONCO CATHETER HAD AN AIR LEAK. THERE WAS NO REPORTED PATIENT OUTCOME.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED NO VISIBLE DEFECTS. THE RETURNED UNIT WAS INFLATED USING THE PARAMETERS SET OUT IN IF001 AND THE TRACHEAL CUFF WOULD NOT INFLATE. EXAMINATION OF THE TRACHEAL CUFF BODY WAS DONE USING THE MICROVU AND SHOWED A SMALL HOLE TO BE 0.4 MM IN DIAMETER. IT WAS REPORTED THAT THE CUFF OF THE BRONCO CATHETER HAD AN AIR LEAK. 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) WITHIN THE INTUBATION ROUTE 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. IF EITHER CUFF IS DAMAGED, THE TUBE SHOULD NOT BE USED. 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.