Description of Event or Problem · 0
THIS LETTER IS TO INFORM YOU OF RECEIPT OF INFORMATION ABOUT AN ADVERSE EVENT REGARDING A PRODUCT WHICH (B)(6) DID NOT MANUFACTURE OR IMPORT. THE REPORT COMES FROM DR. (B)(6) AT (B)(6) MEDICAL CENTER IN (B)(6) CONCERNING A .018 NITREX WIRE THAT WAS 300CM IN LENGTH (REF#N183001) MANUFACTURED BY: MEDTRONIC. IT WAS REPORTED THAT DURING A CARDIOMEMS SENSOR IMPLANT PROCEDURE, THE 300 CM .018 NITREX WIRE CAME BACK AWAY FROM THE DELIVERY SITE WITH THE CARDIOMEMS SENSOR ON IT. THE CARDIOMEMS DELIVERY CATHETER WAS REMOVED. SEVERAL ATTEMPTS WERE MADE TO ACCESS THE DELIVERY SITE, BUT THEY WERE UNSUCCESSFUL DUE TO THE PATIENT'S TORTUROUS ANATOMY. THE PATIENT'S PULMONARY VALVE WAS VERY STIFF AND NOT ALLOWING THE PHYSICIAN TO GAIN ACCESS TO EITHER THE LPA OR RPA. AFTER 30 MINUTES OF TROUBLESHOOTING, THE PHYSICIAN DECIDED TO CANCEL THE PROCEDURE DUE TO THE PATIENT'S DIFFICULT ANATOMY. THE SENSOR AND DELIVERY CATHETER WERE DISCARDED AFTER USE. NO IMPLANT OCCURRED. THE PHYSICIAN WIRED DOWN INTO THE TARGET VESSEL USING AN .018 NITREX WIRE THAT WAS 300CM IN LENGTH (REF#N183001). ONCE THE NITREX WIRE WAS POSITIONED, THE PA CATHETER WAS REMOVED AND THE CARDIOMEMS DELIVERY CATHETER WAS LOADED ONTO THE .018 NITREX WIRE AFTER IT WAS PROPERLY "PREPPED". AS THE DELIVER CATHETER WAS MAKING ITS LAST FEW CENTIMETERS TOWARDS THE DELIVERY SITE, THE PHYSICIAN'S WIRE CAME BACK AND WE NO LONGER HAD A NICE SUPPORTING WIRE INTO THE TARGET VESSEL. THE PHYSICIAN HAD TO REMOVE THE CARDIOMEMS DELIVERY CATHETER WITH THE CARDIOMEMS STILL ATTACHED AND INTACT. EVENT DATE: JAN 29, 2025 PLEASE DO NOT HESITATE TO CONTACT THE ACCOUNT DIRECTLY FOR FURTHER INFORMATION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).