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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 SOUNDSTAR CATHETER, AND WHEN THE CATHETER WAS REMOVED FROM THE PACKAGE THERE WAS A PIECE OF TAPE STUCK ON THE BLACK PART OF THE HANDLE THAT CONNECTS TO THE ECO CABLE. THE TAPE WAS CLEAR/COLORLESS, AND TEXTURED. THE TAPE DID NOT APPEAR TO BE PART OF THE PACKAGING ITSELF. NO VISIBLE DAMAGE TO THE CATHETER WAS OBSERVED. THE USER DID NOT FEEL COMFORTABLE USING IT. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THERE WAS NO PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION WITH A REPROCESSED SOUNDSTAR® ECO 8F G DIAGNOSTIC ULTRASOUND CATHETER (R10439236/2207304), AND WHEN THE CATHETER WAS REMOVED FROM THE PACKAGE THERE WAS A PIECE OF TAPE STUCK ON THE BLACK PART OF THE HANDLE THAT CONNECTS TO THE ECO CABLE. ONE (1) PHOTO ACCOMPANIED THE COMPLAINT FILE IN WHICH ONLY THE ECO CONNECTOR AND SWIFTLINK CONNECTOR OF A DEVICE CAN BE SEEN. A PIECE OF MEDICAL TAPE CAN BE SEEN ON THE ECO CONNECTOR OF A DEVICE. NO DAMAGES WERE OBSERVED, AS THE REST OF THE DEVICE IS NOT SHOWN IN THE PHOTO. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION ON 18-JUL-2024. A NON-STERILE REPROCESSED SOUNDSTAR® ECO 8F G DIAGNOSTIC ULTRASOUND CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND A PIECE OF MEDICAL TAPE WAS FOUND ON THE ECO CONNECTOR OF THE DEVICE. THE ORIGINAL PACKAGING WAS NOT RETURNED FOR EVALUATION. NO APPEARANCE OF DAMAGES WAS OBSERVED. THE PHYSICAL MARK ON THE DEVICE INDICATED IT HAD BEEN REPROCESSED ONE (1) TIME. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 2207304, AND NO INTERNAL ACTIONS OR MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THE ISSUE REPORTED REGARDING A PIECE OF TAPE STUCK ON THE BLACK PART OF THE HANDLE WAS CONFIRMED BASED ON THE MEDICAL TAPE FOUND ON THE ECO CONNECTOR. WITH THE LIMITED INFORMATION AVAILABLE, AND EVIDENCE OBTAINED FROM THE INSPECTION, THERE IS NO CLEAR INSIGHT INTO THE ROOT CAUSE AND/OR EXACT CONTRIBUTING FACTORS THAT MAY HAVE RESULT IN MEDICAL TAPE IN THE ECO CONNECTOR SINCE, 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 DEFECTIVE DEVICES FROM LEAVING THE FACILITY. THIS ISSUE IS BEING ADDRESSED THROUGH STERILMED¿S QUALITY SYSTEM AND ACTIONS ARE BEING TAKEN ON THE SUPPLIER¿S SIDE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: PC-(B)(4).