IMAGING CATHETER

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 IMAGING CATHETER AND DURING PREP, WHEN ATTEMPTING TO OPEN THE PACKAGING, THE SIDES WERE GLUED TIGHTLY, WHICH CAUSED THE PACKAGING TO RIP DOWN THE MIDDLE. HOWEVER THE CATHETER STAYED ADHERED ON THE SIDES RENDERING IT NON-STERILE. THERE WAS NO PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED IMAGING CATHETER AND DURING PREP, WHEN ATTEMPTING TO OPEN THE PACKAGING, THE SIDES WERE GLUED TIGHTLY, WHICH CAUSED THE PACKAGING TO RIP DOWN THE MIDDLE. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. A NON-STERILE REPROCESSED SOUNDSTAR® ECO 8F G DIAGNOSTIC ULTRASOUND CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT THE OUTER PACKAGE AND INNER POUCH OF THE DEVICE WERE NOT RETURNED FOR EVALUATION. THE CATHETER WAS INSPECTED, AND NO DAMAGES WERE OBSERVED. THE PHYSICAL MARKS ON THE DEVICE INDICATED THAT IT HAD BEEN REPROCESSED TWO (2) TIMES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED REGARDING THE CATHETER BEING ADHERE TO THE SIDES OF THE PACKAGING COULD NOT BE CONFIRMED SINCE NO RESIDUES OF ADHESIVE NOR DAMAGES ON THE CATHETER WERE NOTED. WITH THE LIMITED INFORMATION AVAILABLE, AND THE RESULTS OBTAINED FROM THE PRODUCT ANALYSIS, THERE IS NO EVIDENCE THAT THE DEVICE WAS POORLY SECURED OR OVERTIGHTENED INSIDE THE PACKAGE, AND NO FURTHER EVALUATION COULD BE CONDUCTED WITHOUT THE REST OF THE PACKAGING. 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. 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 ON 1-NOV-2023. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. MANUFACTURER'S REF. NO: (B)(4).