CLEANCUT® RCL 40 ROTATING AORTIC PUNCH 4.0 MM

Additional Manufacturer Narrative

EVENT SUMMARY: ON (B)(6) 2026, THE COMPLAINANT REPORTED THAT DURING AN AORTIC PUNCH PROCEDURE, THE SURGEON OBSERVED PATIENT TISSUE STUCK TO THE TIP OF THE DEVICE AFTER THE INITIAL CUT. THE TISSUE WAS RETRACTED INTO THE PUNCH. WHEN A SECOND PUNCH WAS MADE WITH THE SAME DEVICE, THE RETAINED TISSUE WAS RELEASED BACK INTO THE PATIENT'S AORTA. THE SURGEON THEN PERFORMED AN AORTOTOMY TO RETRIEVE THE TISSUE. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 30 MINUTES. NO PERMANENT PATIENT INJURY OCCURRED; THE PATIENT WAS TREATED WITH STANDARD ANESTHETICS AND HEPARINIZED SALINE. DEVICE RETURN STATUS: THE DEVICE (LOT 78426) HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO PHYSICAL EVALUATION HAS BEEN PERFORMED. MANUFACTURER INVESTIGATION: THE COMPLAINT WAS REVIEWED BY THE MANUFACTURER'S REGULATORY AND ENGINEERING TEAMS. INSTRUCTIONS FOR USE (IFU) FOR THE RCL40 AORTIC PUNCH CLEARLY STATE: "WARNING: REMOVE THE PUNCH FROM THE AORTA WITHOUT RELEASING THE PLUNGER TO ENSURE REMOVAL OF THE EXCISED PLUG OF THE AORTIC TISSUE." THE REPORTED EVENT DESCRIPTION INDICATES THE USER RELEASED THE PLUNGER WHILE THE PUNCH WAS STILL INSIDE THE AORTA, CAUSING THE EXCISED TISSUE PLUG TO BE RETAINED AND SUBSEQUENTLY RELEASED INTO THE VESSEL UPON A SECOND ACTUATION. THIS IS A DEVIATION FROM THE IFU. ROOT CAUSE: THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR - FAILURE TO FOLLOW THE SPECIFIED WARNING AND PROCEDURAL INSTRUCTIONS. NO MANUFACTURING OR DESIGN DEFECT WAS IDENTIFIED. CONCLUSION: THIS EVENT WAS CAUSED BY IMPROPER DEVICE USE. THE MANUFACTURER IS IN CONTACT WITH THE HOSPITAL AND IS PLANNING TO SEND PERSONNEL ON-SITE TO PROVIDE ADDITIONAL TRAINING ON PROPER USE OF THE AORTIC PUNCH. NO FURTHER CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED FROM THE MANUFACTURER. THIS REPORT IS FILED AS A MALFUNCTION THAT COULD HAVE LED TO SERIOUS INJURY (STROKE) IF THE TISSUE HAD NOT BEEN RETRIEVED, CONSISTENT WITH 21 CFR 803.50(A).

Description of Event or Problem

ON 04/16/2026, QUEST MEDICAL WAS CONTACTED ON BEHALF OF UMASS MEMORIAL HEALTH REGARDING PRODUCT RCL40, LOT NUMBER 78426. FULL STATEMENT FROM REPORT: SURGEON IS SEEING PATIENT'S TISSUE STUCK TO THE TIP OF THE AORTIC PUNCH AFTER MAKING THE INITIAL CUT IN THE AORTA AND IS RETRACTED INTO THE DEVICE AFTER FIRST PUNCH IS MADE. IN ONE CASE, THE TISSUE WAS RETRACTED INTO THE PUNCH AND THEN THE TISSUE PIECE WAS RELEASED BACK INTO THE AORTA WHEN A SECOND PUNCH WAS MADE WITH THE SAME DEVICE. SURGEON HAD TO GO INTO THE AORTA AND RETRIEVE THE TISSUE THAT THE PUNCH HAD SENT INTO THE PATIENT FROM INITIAL CUT. IF TISSUE IS STUCK IN THE AORTIC PUNCH, THIS TISSUE CAN BE SENT INTO THE PATIENT WHEN THE SECOND CUT IS MADE AND IF NOT RETRIEVED, WHEN PATIENT GOES OFF BYPASS, THIS REMAINING TISSUE INSIDE THE AORTA COULD CAUSE A STROKE. SURGERY WAS DELAYED BY 30 MINUTES. STANDARD CV SURGERY ANESTHETICS AND HEPARINIZED SALINE WAS ADMINISTERED. INTERVENTION WAS REQUIRED. INTERVENTION: THE SURGEON HAD TO MAKE A CUT IN THE AORTA TO RETRIEVE THE TISSUE FROM THE AORTIC PUNCH THAT HAD BEEN SENT BACK INTO THE AORTA AS THE SECOND PUNCH WAS MADE.