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Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F ULTRASOUND CATHETER. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WITH ANOTHER DEVICE WHICH REQUIRED PERICARDIOCENTESIS. THE PHYSICIAN ATTEMPTED ABLATION INSIDE THE CORONARY SINUS (CS), BUT DUE TO DIFFICULT ANATOMY IT WAS ABORTED. THE PHYSICIAN ATTEMPTED BOTH SHEATH AND CATHETER MANIPULATION INSIDE THE CS FOR APPROXIMATELY 60 MINUTES. AFTER ABORTING THE ABLATION, A PERICARDIAL EFFUSION WAS DISCOVERED BY THE POST CASE INTRACARDIAC ECHOCARDIOGRAM (ICE) AND CONFIRMED BY ICE CATHETER. THE PHYSICIAN ATTEMPTED TO PERFORM PERICARDIOCENTESIS WHICH WAS ABORTED DUE TO INABILITY TO GAIN ACCESS TO THE PERICARDIAL SPACE, AND THE PHYSICIAN'S IMPRESSION OF THE EFFUSION DECREASING. THE PATIENT¿S CONDITION WORSENED, AND THE PATIENT BEGAN SHOWING TAMPONADE PHYSIOLOGY LATER IN THE DAY AND WAS BROUGHT BACK TO THE LAB FOR PERICARDIOCENTESIS WHICH WAS SUCCESSFUL IN REMOVING 300ML OF FLUID. THE PATIENT WAS STABLE. LAST KNOWN STATUS OF THE PATIENT IS IMPROVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF CONTINUED MONITORING. ONE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH BAYLIS NRG. PRIOR TO NOTING THE PERICARDIAL EFFUSION, ABLATION WAS PERFORMED. THE PATIENT DID NOT REQUIRE CARDIAC SURGERY. NO EVIDENCE OF STEAM POP. THE PROCEDURAL ACTIVATED CLOTTING TIME WAS 350 SECONDS. THE FLOW SETTING WAS STANDARD SETTINGS. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE VISITAG MODULE PARAMETERS FOR STABILITY USED WERE 2MM, 3 SECONDS AND 25% OF 3G. NO ADDITIONAL FILTER WAS USED WITH THE VISITAG. THE COLOR OPTION PROSPECTIVELY USED WAS TAG INDEX. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS DIFFICULT PATIENT ANATOMY ALONG WITH MANIPULATION OF CATHETERS AND SHEATHS INSIDE THE CS. THE SMARTTOUCH SURROUND FLOW CATHETER, DECANAV CATHETER, VIZIGO SHEATH, AND SL1 SHEATH WERE ALL USED IN ATTEMPTING TO ACCESS THE CS. HOWEVER, IT IS UNCLEAR WHICH SPECIFIC DEVICE LED TO THE EFFUSION. THE REPROCESSED SOUNDSTAR ECO 8F ULTRASOUND CATHETER WAS ASSESSED AS CONCOMITANT FOR THE ORIGINAL REPORTED EVENT AND THE EVENT WAS REPORTED UNDER THE REPROCESSED DECANAV EP CATHETER. THE REPROCESSED SOUNDSTAR ECO 8F ULTRASOUND CATHETER WAS RETURNED TO STERILMED FOR FURTHER EVALUATION AND A SCRATCH WAS IDENTIFIED IN THE MIDDLE OF THE SHAFT, LEAVING A THIN SECTION PARTIALLY DETACHED. THIS DAMAGE EXPOSED INTERNAL CABLES, WHICH ALSO APPEAR TO HAVE SUSTAINED SCRATCHES, POTENTIALLY COMPROMISING THEIR INTEGRITY. THIS FINDING IS MDR REPORTABLE.

Additional Manufacturer Narrative

A NON-STERILE REPROCESSED SOUNDSTAR® ECO 8F G DIAGNOSTIC ULTRASOUND CATHETER (R10439236/2241177) WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS PERFORMED, AND A SCRATCH WAS IDENTIFIED IN THE MIDDLE OF THE SHAFT, LEAVING A THIN SECTION PARTIALLY DETACHED. THIS DAMAGE EXPOSED THE INTERNAL CABLES, WHICH ALSO APPEAR TO HAVE SUSTAINED SCRATCHES, POTENTIALLY COMPROMISING THEIR INTEGRITY. NO OTHER DAMAGE WAS FOUND. THE PHYSICAL MARK ON THE DEVICE INDICATED THAT IT HAD BEEN REPROCESSED ONE (1) TIME. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE CATHETER WAS CONNECTED TO CARTO 3 SYSTEM AND ULTRASOUND SYSTEM, AND IT WAS RECOGNIZED AND VISUALIZED WITHOUT ANOMALIES. NO ERRORS APPEARED ON THE SCREEN OF EITHER OF THE SYSTEMS. THE REPROCESSED SOUNDSTAR® ECO 8F G DIAGNOSTIC ULTRASOUND CATHETER WAS UTILIZED TO DETECT THE PERICARDIAL EFFUSION AND IS CONSIDERED A CONCOMITANT PRODUCT IN THIS EVENT. SINCE THERE IS NO ALLEGED QUALITY ISSUE, NO FURTHER INVESTIGATION WILL BE PERFORMED AT THIS TIME. THE RETURNED CONDITION WAS NOT ORIGINALLY REPORTED, AND THE EXACT TIME OF OCCURRENCE CANNOT BE DETERMINED; THEREFORE, THIS IS NOT CONSIDERED RELATED TO THE ISSUE REPORTED. AS PART OF STERILMED¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 REF. NO: (B)(4).