CATHETER SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND FOR USE ON GE IMAGING SYSTEM 10F

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION WITH A REPROCESSED CATHETER SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND FOR USE ON GE IMAGING SYSTEM 10F CATHETER AND WHEN MANIPULATING THE CATHETER, THE AV NODE WAS TOUCHED AND THE PATIENT EXPERIENCED COMPLETE HEART BLOCK, WHICH REQUIRED PACEMAKER INSERTION. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. A NON-STERILE REPROCESSED CATHETER SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND FOR USE ON GE IMAGING SYSTEM 10F WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND NO APPEARANCE OF DAMAGES WAS OBSERVED. THE PHYSICAL MARK ON THE DEVICE INDICATED THAT IT HAD BEEN REPROCESSED ONE (1) TIME. THE CATHETER WAS CONNECTED TO THE CARTO 3 SYSTEM AND ULTRASOUND SYSTEM, AND IT WAS RECOGNIZED AND VISUALIZED. NO ERRORS APPEARED ON THE SCREEN OF NONE OF THE SYSTEMS. THE ACOUSTIC IMAGE WAS CONFIRMED TO BE DISPLAYED BLURRY. THE TRANSDUCER WAS TESTED, AND THE SENSOR ARRAY VALUES WERE FOUND TO BE OUTSIDE OF THE ACCEPTANCE VALUES. LASTLY, THE TRANSDUCER WAS INSPECTED UNDER MICROSCOPIC MAGNIFICATION, AND EVIDENCE OF DELAMINATION WAS OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. NO FURTHER INVESTIGATION IS BEING CONDUCTED AS THERE IS NO ALLEGED QUALITY ISSUE AGAINST THE REPROCESSED CATHETER. THIS INVESTIGATION IS CONSIDERED COMPLETE AT THIS TIME; IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER TIME, THIS INVESTIGATION WILL BE UPDATED, AND FURTHER ACTIONS CAN BE TAKEN AS NEEDED. THE BLURRY QUALITY OF THE IMAGE WAS NOT ORIGINALLY REPORTED, NOR THE DELAMINATION FOUND ON THE TRANSDUCER. THE EXACT TIME OF OCCURRENCE CANNOT BE DETERMINED; IT IS SUGGESTED THAT THIS DAMAGE COULD BE THE RESULT OF THE POST-OPERATIVE HANDLING/INSPECTION OF THE DEVICE, AND IT IS NOT RELATED TO THE ISSUE ENCOUNTERED DURING THE PROCEDURE SINCE THE PHYSICIAN DOES NOT ATTRIBUTE THE CAUSE OF THE EVENT TO BE RELATED TO THE PRODUCTS USED. AS PART OF STERILMED'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGES FROM LEAVING THE FACILITY. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. 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).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION WITH A REPROCESSED CATHETER SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND FOR USE ON GE IMAGING SYSTEM 10F CATHETER AND THE PATIENT EXPERIENCED COMPLETE HEART BLOCK THAT REQUIRED PACEMAKER INSERTION. WHEN MANIPULATING THE CARTO SOUND CATHETER, THE AV NODE WAS TOUCHED, AND THE PATIENT WENT INTO COMPLETE HEART BLOCK. THE AFIB PROCEDURE WAS THEN CANCELLED, AND A PERMANENT PACEMAKER WAS INSERTED. THE PATIENT WAS REPORTED TO BE STABLE, AND THEIR OUTCOME IS UNCHANGED. THE PHYSICIAN DOES NOT ATTRIBUTE THE CAUSE OF THE EVENT TO BE RELATED TO THE PRODUCTS USED. NO TRANSSEPTAL PUNCTURE PERFORMED.