NA

Additional Manufacturer Narrative

FOUR (4) PHOTOS ACCOMPANIED THE COMPLAINT FILE. THE FIRST PHOTO SHOWS THE DEVICE OUTSIDE THE BAG, SPECIFICALLY THE AREA WHERE THE ELECTRODES WERE LOCATED. DAMAGE WAS FOUND ON THE TIP OF THE DEVICE. THE DOME IS VISIBLE, ALONG WITH THE EXPULSION OF THE DEVICE'S CABLES. THE SECOND PHOTO ALSO SHOWS THE TIP OF THE DEVICE IN A DIFFERENT POSITION, WHERE TWO CABLES ARE EXPOSED, ONE CONNECTED TO THE DOME AND THE OTHER EXPOSED. THE THIRD PHOTO SHOWS THE SAME DAMAGE, WITH A CLOSER VIEW OF THE CABLE EXPOSED FOR APPROXIMATELY 1 CM. THE FOURTH PHOTO SHOWS THE DAMAGE AT THE FRONT OF THE TIP, WHERE THE DOME IS EXPOSED ALONG WITH THE CABLE FROM THE SHAFT OF THE DEVICE. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED REGARDING THE BROKEN TIP OF THE CATHETER WAS CONFIRMED. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTOS PROVIDED. IF THE PRODUCT IS RECEIVED AFTER THIS INVESTIGATION, AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. 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. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE AND AFTER VISUALLY INSPECTING THE REPROCESSED EP CATHETER WEBSTER CS UNI-DIRECTIONAL DECAPOLAR OUT OF THE PACKAGE, THE TIP ELECTRODE WAS NOTICED TO BE COMING OFF AND WAS ONLY HELD ON BY THE INTERNAL WIRE. THERE WAS NO DAMAGE TO THE PACKAGING. PACKAGING BOX WAS ONLY OPENED IMMEDIATELY PRIOR TO CASE DURING SETUP. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE AND AFTER VISUALLY INSPECTING THE REPROCESSED EP CATHETER WEBSTER CS UNI-DIRECTIONAL DECAPOLAR OUT OF THE PACKAGE, THE TIP ELECTRODE WAS NOTICED TO BE COMING OFF AND WAS ONLY HELD ON BY THE INTERNAL WIRE. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. A NON-STERILE REPROCESSED EP CATHETER WEBSTER CS UNI-DIRECTIONAL DECAPOLAR WITH AUTO ID CS-D CURVE WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS PERFORMED, REVEALING THAT THE DOME TIP WAS DISPLACED FROM ITS ORIGINAL POSITION BY APPROXIMATELY 1 CM FROM THE SHAFT. THE LOT NUMBER INDICATED THAT IT HAD BEEN REPROCESSED ONE (1) TIME. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE OF THE TIP ELECTRODE DETACHING WAS CONFIRMED BASED ON THE FINDINGS OUTLINED ABOVE; HOWEVER, THE UNDERLYING CAUSE OF THE BREAKAGE REMAINS UNDETERMINED. WITH THE LIMITED INFORMATION AVAILABLE, THIS REMAINS SPECULATIVE. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. AS PART OF STERILMED'S QUALITY PROCESS, ALL THE DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DEFECTIVE DEVICES FROM LEAVING THE FACILITY. THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).