DIAGNOSTIC EP CATH

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AND ELECTROPHYSIOLOGY STUDY WITH A DIAGNOSTIC EP CATHETER AND THE CATHETER ONLY HAD TWO WORKING POLES WITH NOISE ON THE OTHER THREE. THE CATHETER WAS EXCHANGED, AND THE ISSUE RESOLVED. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS EVENT IS NOT REPORTABLE. UPON RECEIVING THE DEVICE FOR EVALUATION, VISUAL INSPECTION WAS PERFORMED, AND THE SHAFT ABOVE THE ELECTRODE #2 WAS MELTED. THIS FINDING IS REPORTABLE.

Additional Manufacturer Narrative

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 THE SHAFT ABOVE THE ELECTRODE #2 WAS MELTED. NO OTHER DAMAGES WERE NOTED. THE LOT NUMBER OF THE DEVICE INDICATED IT HAD BEEN REPROCESSED FOUR (4) TIMES. MICROSCOPIC INSPECTION ON THE MELTED CONDITION ON THE SHAFT REVEALED THAT AS A RESULT OF THIS CONDITION, THE BRAIDED WIRE AND INTERNAL WIRES WERE BROKEN. THE CATHETER WAS CONNECTED TO THE CARTO 3 SYSTEM, AND THE DEVICE WAS RECOGNIZED; HOWEVER, THE DEVICE WAS NOT VISUALIZED, AND NO NOISE WAS DISPLAYED. THE DEVICE HISTORY RECORDS (DHR) FOR LOT NUMBER 2201781 WERE REVIEWED AND NO EVIDENCE OF DEFICIENCIES DURING THE REPROCESSING WAS FOUND. THE SERIAL NUMBER (B)(6) WAS RECORDED AS NOT DEFECTIVE DURING THE VISUAL INSPECTION. ALL DEFECTIVE PIECES WERE PROPERLY SCRAPPED AND ACCOUNTED FOR, AND NO INTERNAL ACTIONS WERE GENERATED. THE ISSUE REPORTED REGARDING THE NOISE ON THE POLES COULD NOT BE EVALUATED AS THE DAMAGED CONDITION OF THE SHAFT OF THE DEVICE PREVENTED PROPER FUNCTIONAL TESTING. THE DAMAGED CONDITION WAS NOT ORIGINALLY REPORTED, AND THE EXACT TIME OF OCCURRENCE CANNOT BE DETERMINED. IT IS SUGGESTED THAT THIS CONDITION COULD HAVE BEEN THE RESULT OF THE POST-OPERATIVE HANDLING OF THE DEVICE; THEREFORE, THIS IS NOT CONSIDERED RELATED TO THE ISSUE REPORTED. AS PART OF STERILMED'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGES 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).