SOUNDSTAR® ECO 10F DIAGNOSTIC ULTRASOUND CATHETER

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A SOUNDSTAR® ECO 10F DIAGNOSTIC ULTRASOUND CATHETER AND THERE WAS A PIECE OF WHITE TAPE OR DEBRIS STUCK ON THE SHAFT OF THE CATHETER, APPROXIMATELY 12 INCHES FROM THE CATHETER TIP. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. A NON-STERILE REPROCESSED SOUNDSTAR® ECO 10F DIAGNOSTIC ULTRASOUND CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND THE SERIAL NUMBER LABEL WAS NOT ATTACHED TO THE SHAFT OF THE CATHETER AND NOT RETURNED FOR EVALUATION. LABEL RESIDUES WERE FOUND AT 10.23 INCHES (26 CM) FROM THE DISTAL END OF THE CATHETER. NO FOREIGN PARTICLES WERE IDENTIFIED ON THE CATHETER. ADDITIONALLY, ONE (1) KINKED CONDITION WAS FOUND AT 4.92 INCHES (12.5 CM) FROM THE PROXIMAL END OF THE CATHETER. NO OTHER DAMAGES WERE FOUND. THE PHYSICAL MARK ON THE DEVICE INDICATED IT HAD BEEN REPROCESSED ONE (1) TIME. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE ISSUE REPORTED REGARDING WHITE TAPE BEING STUCK ON THE SHAFT OF THE CATHETER WAS CONFIRMED, AS THE RESIDUES FOUND BELONGED TO THE DETACHED SERIAL NUMBER LABEL. IT IS SUGGESTED THAT THE SERIAL NUMBER LABEL COULD HAVE BEEN SLID DURING THE REMOVAL OF THE CATHETER FROM ITS PACKAGING LEAVING RESIDUES. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. THE KINKED CONDITION ON THE SHAFT WAS NOT ORIGINALLY REPORTED, THE EXACT TIME OF OCCURRENCE CANNOT BE DETERMINED; 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 DEFECTIVE DEVICES 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).

Additional Manufacturer Narrative

ONE (1) PHOTO ACCOMPANIED THE COMPLAINT FILE IN WHICH A WHITE PARTICLE CAN BE SEEN ADHERED TO A SHAFT OF A CATHETER. NO OTHER DAMAGES CAN BE OBSERVED AS THE REST OF THE CATHETER WAS NOT SHOWN IN THE PHOTO. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT WAS CONFIRMED. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTO PROVIDED. FURTHER ASSESSMENT WILL BE PERFORMED ONCE THE DEVICE RETURNED. AS PART OF STERILMED'S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A SOUNDSTAR® ECO 10F DIAGNOSTIC ULTRASOUND CATHETER AND THERE WAS A PIECE OF WHITE TAPE OR DEBRIS STUCK ON THE SHAFT OF THE CATHETER, APPROXIMATELY 12 INCHES FROM THE CATHETER TIP. THE TAPE/DEBRIS WAS NOT BELIEVED TO BE THE TRANSITIONAL PIECE WHICH IS A WHITE LABEL. THE STERILITY OF THE CATHETER WAS QUESTIONABLE. THE CATHETER WAS EXCHANGED TO CONTINUE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.