CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID

Additional Manufacturer Narrative

THE INVESTIGATION WAS COMPLETED ON (B)(6) 2023. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4)

Additional Manufacturer Narrative

IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY STERILMED, INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED, INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER:(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID. THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETELY STOPPED DUE TO THE PATIENT HAVING A PERICARDIAL EFFUSION. THEY STATED THAT THEY CROSSED INTO THE LEFT ATRIUM AND MAPPED. THE PHYSICIAN NOTICED THAT THERE WAS AN EFFUSION PRESENT IN AN UNKNOWN LOCATION. THE PROCEDURE WAS STOPPED AND A PERICARDIOCENTESIS WAS PERFORMED. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE, REPROCESSED SOUNDSTAR ECO CATHETER (LOT #2189176), REPROCESSED CS CATHETER (PREMIER PLURAL), AND A VIZIGO SHEATH WERE REMOVED FROM THE PATIENT'S BODY. THE PATIENT WAS NOT STABLE AT THAT TIME AND THEY DID NOT KNOW THE PATIENT'S PROGNOSIS AT THAT TIME. THE PHYSICIAN HAD CALLED CT SURGERY FOR A CONSULT. THEY ALSO STATED THAT THE PHYSICIAN DID NOT KNOW WHAT CAUSED THE EFFUSION. ADDITIONAL INFORMATION WAS RECEIVED STATING NO ABLATION WAS CARRIED OUT IN THE PROCEDURE AND THE EVENT OCCURRED DURING THE MAPPING PHASE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.