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Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR® CATHETER AND UPON OPENING THE PRODUCT PACKAGE, THERE WAS A FOREIGN, EXTRA BLACK PIECE OF PLASTIC AROUND THE VERY DISTAL TIP. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. A NON-STERILE REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER FOR USE ON SIEMENS IMAGING SYSTEM WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIPT OF THE DEVICE, A VISUAL INSPECTION WAS PERFORMED AND THE TRANSITIONAL PIECE WAS NEAR THE TIP OF THE CATHETER AS WELL THE SERIAL NUMBER TAG WAS NOT ATTACHED TO THE SHAFT OF THE CATHETER; HOWEVER, ADHESIVE RESIDUES WERE FOUND INDICATING THAT IT WAS PREVIOUSLY ATTACHED. NO OTHER DAMAGE WAS FOUND ON THE DEVICE. THE PHYSICAL MARK ON THE DEVICE INDICATED THAT IT HAD BEEN REPROCESSED (3) TIMES. 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 PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 7-MAR-2025. SECTION D9 HAS BEEN UPDATED. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR® CATHETER AND UPON OPENING THE PRODUCT PACKAGE, THERE WAS A FOREIGN, EXTRA BLACK PIECE OF PLASTIC AROUND THE VERY DISTAL TIP. THE BLACK PLASTIC PIECE WAS UNABLE TO BE REMOVED. THERE WAS NO DAMAGE TO THE PACKAGING. THE SOUNDSTAR® CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

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).