DIAGNOSTIC EP CATH

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION ABLATION PROCEDURE WITH A REPROCESSED EP DIAGNOSTIC CATHETER AND WHEN THE CATHETER WAS OPENED THERE WERE SOME FUZZ ON PART OF THE CATHETER. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. A NON-STERILE REPROCESSED CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND NO APPEARANCE OF DAMAGES WAS OBSERVED. NO FOREIGN MATTER/RESIDUES WERE OBSERVED ON THE CATHETER. THE LOT NUMBER OF THE DEVICE INDICATED IT HAD BEEN REPROCESSED ONE TIME. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED REGARDING THE FUZZ ON THE CATHETER WAS NOT CONFIRMED AS NO FOREIGN MATTER/FOREIGN RESIDUES WERE FOUND ON THE CATHETER, AND NO FURTHER INVESTIGATION CAN BE PERFORMED WITHOUT THE ORIGINAL 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 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 REF. NO: (B)(4).

Additional Manufacturer Narrative

THE PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 5-MAR-2024. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. SECTION D9 HAS BEEN UPDATED. MANUFACTURER'S REF. NO: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION ABLATION PROCEDURE WITH A REPROCESSED EP DIAGNOSTIC CATHETER AND WHEN THE CATHETER WAS OPENED THERE WERE SOME FUZZ ON PART OF THE CATHETER. THE PRIMARY PACKAGING OF THE PRODUCT WAS NOT OPENED BEFORE THE SURGERY. THERE WAS NO PHYSICAL DAMAGE, OR ANY OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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).