SHILEY

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: 85864 STYLET STERILE 10FR BX20 X20 LOT: UNKNOWN 85864 STYLET STERILE 10FR BX20 X20 LOT: UNKNOWN 85864 STYLET STERILE 10FR BX20 X20 LOT: UNKNOWN 85864 STYLET STERILE 10FR BX20 X20 LOT: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 TESTING, A PHYSICIAN PROVIDED FEEDBACK REGARDING THE TEN STYLETS, DESCRIBING AS AN UNACCEPTABLE REPLACEMENT DUE TO BEING TOO FLIMSY, NOT HOLDING SHAPE, AND BREAKING OFF EASILY. THERE WAS NO PATIENT INVOLVED.

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 STYLET WAS MISSHAPED AND INSIDE THE PLASTIC SHEATH OF THE STYLET THE METAL CORE IS BROKEN IN THREE PARTS. IT WAS REPORTED THAT A PHYSICIAN PROVIDED FEEDBACK REGARDING THE TEN STYLETS, DESCRIBING AS AN UNACCEPTABLE REPLACEMENT DUE TO BEING TOO FLIMSY, NOT HOLDING SHAPE, AND BREAKING OFF EASILY. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. 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: THIS PRODUCT CANNOT BE ADEQUATELY CLEANED AND/OR STERILIZED BY THE USER IN ORDER TO FACILITATE SAFE REUSE, AND IS THEREFORE INTENDED FOR SINGLE USE. ATTEMPTS TO CLEAN OR STERILIZE THESE DEVICES MAY RESULT IN A BIO INCOMPATIBILITY, INFECTION OR PRODUCT FAILURE RISKS TO THE PATIENT. 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.