EP CATHETER WEBSTER LASSO® 2515 ECO VARIABLE CATHETER

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE, WITH A REPROCESSED EP CATHETER WEBSTER LASSO® 2515 ECO VARIABLE CATHETER AND DURING DEVICE ANALYSIS A MISSING ELECTRODE WAS DISCOVERED. DURING THE PROCEDURE, THE CATHETER WAS INSERTED INTO LEFT ATRIUM AND NOISE WAS OBSERVED ON LASSO POLES 17-18 ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. ALL OTHER INTRACARDIAC AND BODY SURFACE ELECTROGRAM SIGNALS WERE CLEAR. THE CATHETER WAS UNPLUGGED AND RE-PLUGGED, HOWEVER, NOISE REMAINED ON LASSO POLES 17-18. THE CABLE WAS REPLACED, AND THE ERROR REMAINED. A DIFFERENT REPROCESSED LASSO CATHETER WAS USED, AND THE ERROR RESOLVED. THE PROCEDURE CONTINUED WITH NO ADVERSE EVENTS. THIS EVENT IS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO STERILMED FOR EVALUATION IN WHICH THE MISSING ELECTRODE WAS DISCOVERED. THIS FINDING IS MDR REPORTABLE.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. A NON-STERILE REPROCESSED EP CATHETER WEBSTER LASSO® 2515 ECO VARIABLE CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT THE ELECTRODE 17 WAS MISSING FROM THE CATHETER. NO OTHER DAMAGES WERE OBSERVED. THE LOT NUMBER OF THE DEVICE INDICATED IT HAD BEEN REPROCESSED ONE (1) TIME. A FOLLOW UP WAS SENT ON 16-NOV-2023 TO CLARIFY THE MISSING ELECTRODE CONDITION FOUND, AND ON 16-NOV-2023, ADDITIONAL EVENT INFORMATION WAS RECEIVED INDICATING THAT EACH ELECTRODE WAS NOT INSPECTED BEFORE SENDING THE DEVICE FOR ANALYSIS; THE DEVICE IMMEDIATELY WENT FROM THE PATIENT INTO THE PRODUCT RETURN BAG. THE PHYSICIAN DID NOT COMMENT ON ANY DAMAGE TO THE CATHETER BEFORE CONNECTING IT TO THE CARTO, AND THE LAB STAFF DID NOT COMMENT ON ANY DAMAGE TO THE PACKAGING. A MICROSCOPICAL INSPECTION WAS PERFORMED, AND RESIDUES OF POLYURETHANE (PU) WERE NOTED AROUND THE RING OF THE ELECTRODE. AN ELECTRICAL TEST WAS PERFORMED, AND NO ELECTRICAL READINGS WERE OBTAINED FROM ELECTRODES #1, AND #17. A DEVICE HISTORY RECORD WAS PERFORMED, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED REGARDING THE NOISE ON ELECTRODES 17 AND 18 IS CONFIRMED BASED ON THE MISSING ELECTRODE FOUND. WITH THE LIMITED INFORMATION AVAILABLE AND EVIDENCE OBTAINED FROM THE PRODUCT ANALYSIS, A ROOT CAUSE OF THE SEPARATION OF THE ELECTRODE FROM THE CATHETER CANNOT BE DETERMINED; HOWEVER, ACCORDING TO THE RISK DOCUMENTATION, AN ELECTRODE CAN BECOME LIFTED/DAMAGED DURING THE MANIPULATION OF THE CATHETER AND CATHETER USAGE DUE TO EXCESSIVE FORCE APPLIED TO THE CATHETER. THE PU RESIDUES OBSERVED ON THE RING OF THE ELECTRODE INDICATES THAT THE ELECTRODE WAS APPROPRIATELY ASSEMBLED TO THE CATHETER. THERE IS NO INDICATION THAT THE ISSUE REPORTED IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE MANUFACTURING OF THE DEVICE. THIS ISSUE IS BEING ADDRESSED THROUGH STERILMED'S QUALITY SYSTEM, AN INTERNAL ACTION WAS OPENED TO DOCUMENT THE EXTERNAL MANUFACTURER'S INVESTIGATION. 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).

Additional Manufacturer Narrative

IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4). INCORRECT MANUFACTURE DATE PREVIOUSLY PROVIDED. CORRECT MANUFACTURE DATE IS 4-MAY-2023.