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Additional Manufacturer Narrative

THE STERILMED, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 12-NOV-2025. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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) PROCEDURE WITH TWO REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER¿S. CATHETERS BECAME UNSTERILE DUE TO PACKAGING NOT OPENING PROPERLY. INSTEAD OF RIPPING STRAIGHT DOWN, IT WOULD DO SO DIAGONALLY INSTEAD. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE WAS NOT DROPPED. NO OTHER DAMAGE WAS OBSERVED ON THE BOX/PACKAGING OF THE DEVICE BEFORE OPENING. WHEN THE SLEEVE WAS PULLED APART TO EXPOSE THE CATHETER FOR REMOVAL, THE CLEAR PLASTIC FRONT TORE DIAGONALLY INSTEAD OF SEPARATING FROM THE SOLID WHITE BACK LAYER. WHEN THE CATHETER WAS REMOVED, IT SCRAPED ALONG THE DIAGONAL TEAR OF THE PLASTIC AND THE PHYSICIAN BELIEVED IT WAS LIKELY CONTAMINATED. DUE TO AN ABUNDANCE OF CAUTION, THEY ASKED FOR A NEW CATHETER. THE REPORTER WAS ASKED TO KEEP THE SLEEVES (WHICH DISPLAYED THE ISSUE WHEN OPENING) AND THE CATHETERS TO SEND BACK FOR ANALYSIS. THE OTHER PACKAGING DID NOT APPEAR TO BE RELATED TO THE ISSUE OBSERVED AND WERE DISPOSED OF. THE STERILITY ISSUE WAS ASSESSED AS MDR REPORTABLE UNDER BOTH OF THE REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER¿S.

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH TWO REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER¿S. CATHETERS BECAME UNSTERILE DUE TO PACKAGING NOT OPENING PROPERLY. INSTEAD OF RIPPING STRAIGHT DOWN, IT WOULD DO SO DIAGONALLY INSTEAD. NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. THE DEVICE EVALUATION WAS COMPLETED ON 05-FEB-2026. A NON-STERILE REPROCESSED SOUNDSTAR® ECO 8F G DIAGNOSTIC ULTRASOUND CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS PERFORMED AND NO DAMAGE WAS FOUND. THE POUCH WAS RECEIVED INSIDE THE DECONTAMINATION BAG ALONG WITH THE DEVICE AND WAS FOUND OPENED AT ONE END OF THE BAG WITH A DIAGONAL TEAR. THE PHYSICAL MARK ON THE DEVICE INDICATED THAT IT HAD BEEN REPROCESSED TWO (2) TIMES. INFRARED ANALYSIS WAS CONDUCTED THE TEST METHOD LTM-0002 REVISION E "IDENTIFICATION OF MATERIALS BY INFRARED SPECTROSCOPY" AND THE USE OF FT-IR INSTRUMENT WAS PERFORMED TO IDENTIFY THE REASON THE POUCH SEAL WAS REPORTED AS EXCESSIVELY STRONG. STERILMED NON-STERILE POUCH WITH SERIAL NUMBER: (B)(6) AND PRODUCT CODE: R10439236 ASSOCIATED WITH LOT: 2241867 WAS PROVIDED TO QA ANALYTICAL LABORATORY FOR FTIR ANALYSIS. THE SAMPLE IS ASSOCIATED WITH STERILMED PRODUCT COMPLAINT (B)(4). FROM VISUAL INSPECTION, IT CAN BE OBSERVED THAT THE POUCH WAS OPENED FROM THE DISTAL END, INSTEAD OF THE PROXIMAL END. THIS STRONGLY CONTRIBUTES TO THE DIFFICULTY OF OPENING THE POUCH. THE FILM AND LINER OF THE DISTAL SECTION OF THE STERILMED NON-STERILE POUCH WAS DIRECTLY ANALYZED BY INFRARED SPECTROSCOPY WITHOUT FURTHER PREPARATION. THE FT-IR MEASUREMENTS WERE PERFORMED USING AN IS50 NICOLET FT-IR MIR SPECTROPHOTOMETER, EQUIPPED WITH AN ATR ACCESSORY. THE SPECTRUM WAS RECORDED IN THE REGION BETWEEN 4000-650 CM-1, WITH A SPECTRAL RESOLUTION OF 4 CM-1 AND 32 SCANS. THE MAIN COMPOSITION FOR BOTH ENDS IS POLYETHYLENE (PE) WITH NO PROMINENT DIFFERENCES BETWEEN THEM. ALSO, IT CAN BE DENOTED THAT THERE ARE NO VIBRATIONS THAT CAN BE ASSIGNED TO ADHESIVES, WHICH CAN INDICATE THAT NO ADHESIVE IS USED TO CLOSE THE POUCHES. IT CAN BE CONCLUDED THAT THE REASON FOR THE DIFFICULTY OF OPENING THE STERILMED POUCH IS DUE TO TRYING TO OPEN IT FROM THE DISTAL END INSTEAD OF THE PROXIMAL END AS INDICATED BY PROCEDURES. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO INTERNAL ACTIONS WERE IDENTIFIED. BASED ON THE ADDITIONAL INFORMATION AND THE CONDITION IN WHICH THE POUCH WAS RECEIVED, THE REPORTED ISSUE OF LOSS OF STERILITY IS CONFIRMED. ALTHOUGH TESTS WERE PERFORMED ON THE SEAL OF THE POUCH, THEY DID NOT CONFIRM RESISTANCE OF THE PACKAGING. AS PART OF STERILMED'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS, INCLUDING CLEANING, RED INSPECTION, STERILIZATION, AND PACKAGE INSPECTION PRIOR TO SHIPPING DURING THE REPROCESSING PROCESS TO PREVENT CONTAMINATED DEVICES FROM LEAVING THE FACILITY. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).