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Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A REPROCESSED SOUND STAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER, AND A FOREIGN OBJECT WAS NOTICED TO BE ON THE CATHETER WHEN IT WAS REMOVED STRAIGHT OUT OF THE PACKAGING. THE CATHETER WAS THOUGHT TO HAVE A CAP OR A PART OF AN OLD SHEATH, A COUPLE OF INCHES FROM THE TIP OF THE CATHETER. THE PIECE SEEMED STUCK ON THE CATHETER. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THE DEVICE WAS RETURNED TO STERILMED FOR EVALUATION ON 19-MAR-2025. THE DEVICE EVALUATION WAS COMPLETED ON 28-MAR-2025. A NON-STERILE REPROCESSED SOUND STAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER FOR USE ON GE IMAGING SYSTEM WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIPT, THE DEVICE WAS FOUND WITH THE TRANSITIONAL PIECE LOCATED NEAR THE TIP AND A MISSING SERIAL NUMBER TAG ON THE CATHETER SHAFT. NO OTHER DAMAGE WAS NOTED NOR FOREIGN MATERIAL. THE PHYSICAL MARK ON THE DEVICE INDICATED THAT IT HAD BEEN REPROCESSED ONCE. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED AS ¿FOREIGN MATTER¿ WAS NOT CONFIRMED, AS PRODUCT ANALYSIS CONFIRMS THAT THE BLACK PLASTIC OBJECT IS ACTUALLY THE TRANSITIONAL PIECE OF THE CATHETER, WHICH COULD HAVE BEEN DISPLACED DURING REMOVAL FROM PACKAGING. THE INSTRUCTIONS FOR USE (IFU) INDICATES THE FOLLOWING: BEFORE USE, INSPECT THE PACKAGING. DO NOT USE IF OPEN OR DAMAGED. USING ASEPTIC TECHNIQUE, REMOVE THE CATHETER FROM ITS PACKAGE AND PLACE IT IN A STERILE WORKING AREA. INSPECT THE CATHETER CAREFULLY FOR ELECTRODE INTEGRITY AND OVERALL CONDITION. AS PART STERILMED'S QUALITY ASSURANCE PROCESSES INCLUDE COMPREHENSIVE INSPECTIONS THROUGHOUT MANUFACTURING AND REPROCESSING TO PREVENT CONTAMINATION. 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 IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER, AND A FOREIGN OBJECT WAS NOTICED TO BE ON THE CATHETER WHEN IT WAS REMOVED STRAIGHT OUT OF THE PACKAGING. THE CATHETER WAS THOUGHT TO HAVE A CAP OR A PART OF AN OLD SHEATH, A COUPLE OF INCHES FROM THE TIP OF THE CATHETER. THE PIECE SEEMED STUCK ON THE CATHETER. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.