SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER

Additional Manufacturer Narrative

THE INVESTIGATION WAS COMPLETED ON 03-APR-2023. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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. STERILMED MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH TWO SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER¿S AND SUFFERED A CARDIAC PERFORATION AND CARDIAC TAMPONADE WHICH REQUIRED SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. THE REPROCESSED CATHETER (SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER) WAS NOT SHOWING UP ON THE S70 ULTRASOUND MACHINE BUT WAS SHOWING UP ON THE CARTO 3 SYSTEM. THEY REPLACED THE SWIFT LINK CABLE BUT THAT DID NOT RESOLVE THE ISSUE. THE CATHETER WAS REPLACED AND THAT DID NOT RESOLVE THE ISSUE. DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED. THE CALLER REPORTED THERE WERE NO VISIBLE SIGNS ON THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ECO. THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND IT WAS UNKNOWN HOW MUCH FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED. THE ABLATION CATHETER WAS NEVER USED. THE PHYSICIAN WAS PERFORMING A TRANSSEPTAL PUNCTURE AND NOTED A POSSIBLE FLICKER AND POSSIBLE SCREEN FREEZE ON THE ICE IMAGING. THE PHYSICIAN PERFORMED THE TRANSSEPTAL PUNCTURE WITH A NEEDLE. SALES REP REPORTS HE IS 99% SURE IT WAS HEARTSPAN NEEDLE THROUGH ST. JUDE SL SHEATH. THE AORTA WAS PUNCTURED AND LED TO THE EFFUSION. DRAINAGE WAS PERFORMED BUT THE PATIENT REQUIRED SURGICAL INTERVENTION FOLLOWED BY PROLONGED HOSPITALIZATION. PATIENT OUTCOME CURRENTLY IS STABLE BUT STILL HOSPITALIZED. THE SALES REP DID A THOROUGH REVIEW OF THE EVENT WITH AN ULTRASOUND REP AND DETERMINED THAT THE REPROCESSED SOUNDSTAR CATHETERS ARE SUSPECTED TO BE "BAD" AND RELATED TO THE "FLICKER" OR "POSSIBLE IMAGE FREEZE" AS IT IS DIFFICULT TO TELL DURING LIVE IMAGING. THE REPRESENTATIVE CONFIRMS THE SMARTTOUCH SURROUND FLOW CATHETER WAS PRESENT BUT WAS IN PACKAGING ON THE TABLE. THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE REPROCESSED CATHETER¿S (SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER).