BEATING HEART

Additional Manufacturer Narrative

(B)(4);. THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

Description of Event or Problem

IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SYSTEM (3.8MM) WOULDN'T LOAD PROPERLY. THEY SAID HEARTSTRING LOOKED TO BE DEFECTIVE OUT OF PACKAGE. WHEN PROCEEDING THROUGH THE LOADING PROCESS THEY "SQUEEZED". WHICH IS FIRST STEP TO FOLD IT, IT WOULDN'T FOLD PROPERLY WHICH PREVENTED IT FROM LOADING IT INTO THE TUBE PROPERLY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM.

Description of Event or Problem

N/A

Additional Manufacturer Narrative

TW # (B)(4). UPDATED SECTIONS: B4, D9, G3, G6, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 12/26/2024. AN INVESTIGATION WAS CONDUCTED ON 02/04/2025. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THE DELIVERY DEVICE WAS RETURNED INSIDE THE LOADING DEVICE WITH THE WHITE PLUNGER NOT DEPRESSED AND THE BLUE SAFETY ON, WHICH PREVENTS THE WHITE PLUNGER FROM BEING DEPRESSED. THE SEAL WAS OBSERVED IN THE LOADING DEVICE WINDOW. THE DELIVERY DEVICE WAS REMOVED FROM THE LOADING DEVICE WITH NO PHYSICAL OR VISUAL DIFFICULTIES OBSERVED. THE SEAL AND TENSION SPRING ASSEMBLY REMAINED INSIDE THE LOADING DEVICE. THE SEAL AND TENSION SPRING ASSEMBLY WAS REMOVED FROM THE LOADING DEVICE WITH NO PHYSICAL OR VISUAL DIFFICULTIES OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT SEAL OR TENSION SPRING ASSEMBLY. MEASUREMENTS OF THE DELIVERY DEVICE WERE TAKEN; THE INNER DIAMETER WAS MEASURED AT 0.196 INCHES; THE OUTER DIAMETER WAS MEASURED AT 0.219 INCHES (RM2036883). THE LENGTH OF THE DELIVERY TUBE WAS MEASURED AT 2.46INCHES (MCV00004217). THE MEASUREMENT VALUES RECORDED FOR THE DELIVERY TUBE WERE WITHIN THE TOLERANCE SPECIFICATIONS. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "FITTING PROBLEM" WAS CONFIRMED. THE LOT # 3000425725 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM.