N/A

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. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER AND UPON OPENING THE SOUNDSTAR CATHETER, SOME DAMAGE WAS OBSERVED TO THE PLASTIC COATING ON THE SHAFT OF THE CATHETER, EXPOSING INTERNAL MATERIAL. IT WAS BELIEVED THAT THIS DAMAGE WOULD AFFECT INSERTION AND POSE A RISK OF A PIECE OF THE COATING COMING OFF INSIDE THE PATIENT. THEREFORE, A SECOND REPROCESSED SOUNDSTAR WAS OPENED TO COMPLETE THE PROCEDURE. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE PACKAGING. THERE WAS A 15-MINUTE DELAY TO THE PROCEDURE FOR TROUBLESHOOTING THIS EVENT AND ANOTHER NOT REPORTABLE ISSUE WITH ANOTHER CATHETER. THE PHYSICIAN DID NOT FEEL THE PROCEDURAL DELAY WAS CLINICALLY SIGNIFICANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER AND UPON OPENING THE SOUNDSTAR CATHETER, SOME DAMAGE WAS OBSERVED TO THE PLASTIC COATING ON THE SHAFT OF THE CATHETER, EXPOSING INTERNAL MATERIAL. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. A NON-STERILE REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND THE SERIAL NUMBER LABEL WAS MISSING FROM THE STRAIN RELIEF OF THE CATHETER. SCRATCH CONDITIONS WERE NOTED FROM 69.0 CM TO 69.5 CM ON THE SHAFT OF THE CATHETER; THIS MEASUREMENT WAS TAKEN FROM THE PROXIMAL END OF THE CATHETER. NO OTHER DAMAGES WERE NOTED. THE ORIGINAL PACKAGING WAS NOT RETURNED FOR ANALYSIS. PHYSICAL MARK ON THE DEVICE INDICATED IT HAD BEEN REPROCESSED ONE (1) TIME. MICROSCOPIC INSPECTION REVEALED RESIDUES OF ADHESIVE SURROUNDING THE SCRATCH CONDITION ON THE SHAFT. NO INTERNAL WIRES NOR COMPONENTS WERE EXPOSED. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED REGARDING A DAMAGED COATING OF THE SHAFT OF THE CATHETER WAS CONFIRMED BASED ON THE SCRATCHED CONDITION OBSERVED ON THE SHAFT. THE COMPLAINT DOCUMENTED THAT THE DEVICE WAS ALREADY DAMAGED WHEN IT WAS FIRST OPENED; THE EXACT TIME OF OCCURRENCE OF THE SCRATCHED CONDITION CANNOT BE DETERMINED, BUT IT IS SUSPECTED TO BE RELATED TO THE MANIPULATION EXERTED AFTER UNPACKING THE DEVICE SINCE 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. WITHOUT THE ORIGINAL PACKAGING A ROOT CAUSE OF THIS FINDING CANNOT BE ASSIGNED. THE ADHESIVE RESIDUES OBSERVED SURROUNDING THE SCRATCH CONDITION WERE NOT ORIGINALLY REPORTED. THESE RESIDUES COULD BE RELATED TO REMOVING THE SERIAL NUMBER LABEL ON THE STRAIN RELIEF. HOWEVER, WITHOUT THE SERIAL NUMBER LABEL, THIS REMAINS SPECULATIVE, AND IT IS NOT CONSIDERED RELATED TO THE ISSUE REPORTED. 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

THE PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).