IMAGING CATHETER

Additional Manufacturer Narrative

SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. THE MANUFACTURE DATE 09-JAN-2023 AND EXPIRATION DATE 09-JAN-2024 WERE OBTAINED FROM THE LOT NUMBER 2184801 ON 19-MAY-2023. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE. 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 4. 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 PROCEDURE WITH A REPROCESSED IMAGING CATHETER AND WHEN THE CATHETER WAS REMOVED FROM THE PACKAGING IT WAS DISCOVERED THAT THE BLACK COATING AROUND THE DISTAL END OF THE CATHETER WAS PEELING OFF. NO FRAGMENTS WERE GENERATED. THE PRIMARY PACKAGING BOX WAS NOT OPENED BEFORE THE SURGERY. NO PHYSICAL DAMAGE OR OTHER ISSUE WAS OBSERVED ON THE PACKAGE OF THE DEVICE. THE CATHETER WAS REPLACED, AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.