IMAGING CATHETER

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION WITH A REPROCESSED IMAGING CATHETER AND WHEN THE PACKAGE WAS OPENED, THERE WAS A SUBSTANCE THAT LOOKED LIKE BLOOD ON THE HANDLE. THE HOSPITAL STAFF WIPED OFF THE HANDLE WITH THE GAUZE AND SET ASIDE THE CATHETER. THERE WAS NO REPORTED PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD FOR LOT NUMBER 2198080 WAS REVIEWED AND NO EVIDENCE OF DEFICIENCIES DURING THE MANUFACTURING PROCESS WAS FOUND. A MANUFACTURING RECORD EVALUATION WAS ALSO CONDUCTED, AND NO NON-CONFORMANCES WERE GENERATED DURING THE MANUFACTURING PROCESS. THE DEVICE PASSED ALL INSPECTIONS PRIOR TO RELEASE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN THE DEVICE THAT WAS USED DURING THIS PROCEDURE. HOWEVER, THE DEVICE HAS NOT 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).

Additional Manufacturer Narrative

SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO:(B)(4).