CABLE INTERFACE CARTO 3

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED CABLE INTERFACE CARTO 3 AND WHEN PLUGGED IN, THE ELECTROCARDIOGRAM (ECG) SIGNALS DISAPPEARED. THERE WAS NO ECG SIGNAL, IT WAS VERY NOISY AND THERE WAS A LOT OF NOISE ON THE CATHETER SIGNAL. THE SIGNAL ISSUE WAS OBSERVED ON THE BODY SURFACE SIGNAL, THE CARTO 3 SYSTEM® AND RECORDING SYSTEM. THE PHYSICIAN DID NOT HAVE AT LEAST ONE ECG SIGNAL AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. THE ISSUE WAS RESOLVED BY USING A NEW CABLE. THERE WAS NO PATIENT INJURY OR CONSEQUENCE.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. A NON-STERILE REPROCESSED CABLE INTERFACE CARTO 3 WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE CABLE, VISUAL INSPECTION WAS PERFORMED, AND NO APPEARANCE OF DAMAGES WAS OBSERVED. THE PHYSICAL MARKS ON THE DEVICE INDICATED IT HAD BEEN REPROCESSED FOUR (4) TIMES. THE COMPLAINT CABLE FUNCTIONALITY WAS VERIFIED BY USING A LAB SAMPLE CATHETER AND A LAB SAMPLE CABLE; WHEN THEY WERE CONNECTED TO THE CARTO 3 SYSTEM, THE CATHETER WAS RECOGNIZED AND HAD NORMAL RESPONSE, ALL THE CATHETER ELECTRODES WERE DISPLAYED CORRECTLY (I.E., NO BLACK ELECTRODES NOR ELECTRICAL NOISE WAS OBSERVED). THE LAB SAMPLE CABLE WAS REPLACED WITH THE COMPLAINT CABLE, AND NO CHANGES WERE OBSERVED, THE CATHETER STILL HAD NORMAL RESPONSE, AND NO ELECTRICAL NOISE WAS OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REGARDING THE NOISE COULD NOT BE CONFIRMED AS THE AS THE CABLE PERFORMED WITHOUT ANY ISSUES. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE CABLE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. AS PART OF STERILMED¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE NO ISSUES WERE IDENTIFIED, NO CAPA ACTIVITY IS REQUIRED. THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING RECOMMENDATION TO REDUCE ECG NOISE: ¿ KEEP ALL SIGNAL CABLES (FOR EXAMPLE, BODY SURFACE CABLE, CATHETER CABLE, AND RF GENERATOR CABLES) AS FAR AWAY AS POSSIBLE FROM AC FIELDS (FOR EXAMPLE, LOCATION PAD AND CABLING, MONITORS, ISOLATION TRANSFORMERS, POWER SUPPLY, ETC.). IN FIELD D.7A, NO WAS SELECTED BECAUSE THIS IS NOT A SINGLE USE DEVICE, THE CABLE CAN BE REUSED. HOWEVER, THIS DEVICE WAS REPROCESSED BY STERILMED INC. 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).