NA

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 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).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED VIEWFLEX XTRA ICE CATHETER AND DURING THE PROCEDURE, THE TIP OF THE CATHETER BROKE. THE DEVICE WAS ABLE TO BE REMOVED. THE TIP WAS STILL ATTACHED TO THE REST OF THE CATHETER BY THE INTERNAL COMPONENTS. THERE WAS NO PHYSICAL DAMAGE OR ANY OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED VIEWFLEX XTRA ICE CATHETER AND DURING THE PROCEDURE, THE TIP OF THE CATHETER BROKE. PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR LOT 2231092 WAS REVIEWED AND THERE WERE NO IDENTIFIED MANUFACTURING DEFICIENCIES OR INTERNAL ACTION. ALL FINISHED GOODS DEVICES HAD PASSED ALL VISUAL AND FUNCTIONAL CRITERIA PRIOR TO DISTRIBUTION. IF THE DEVICE IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THIS ISSUE IS BEING FURTHER ADDRESSED THROUGH STERILMED'S QUALITY SYSTEM AND ACTIONS ARE BEING TAKEN ON THE SUPPLIER'S SIDE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).