CATHETER EZ STEER BI-DIRECTIONAL CS DEFLECTABLE CURVE TYPE: D-F 12 PIN AUTO ID

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CATHETER EZ STEER BI-DIRECTIONAL CS DEFLECTABLE CURVE TYPE: D-F 12 PIN AUTO ID AND A CATHETER SHAFT DAMAGE-DISTAL ISSUE OCCURRED. THE CATHETER EXHIBITED DAMAGE WHEN TAKEN OUT OF THE BOX. THE STERILMED REPROCESSED CATHETER WAS "CHIPPED AWAY" RIGHT BEHIND THE SECOND ELECTRODE. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS CONTINUED AND COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO DAMAGE TO THE OUTER BOX OR PACKAGING. THE DAMAGE DID NOT RESULT IN WIRES AND/OR BRAID BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THE PACKAGING WAS NOT OPENED PRIOR TO THE PROCEDURE. THE ISSUE WAS ASSESSED AS MDR REPORTABLE FOR THE CATHETER SHAFT DAMAGE-DISTAL.

Additional Manufacturer Narrative

THE PRODUCT HAS NOT RETURNED FOR ANALYSIS, HOWEVER, A PICTURE WAS PROVIDED BY THE CUSTOMER. EVALUATION IS STILL IN PROGRESS. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. 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. 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 BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, 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 REFERENCE NUMBER: (B)(4).

Additional Manufacturer Narrative

THE DEVICE EVALUATION WAS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CATHETER EZ STEER BI-DIRECTIONAL CS DEFLECTABLE CURVE TYPE: D-F 12 PIN AUTO ID AND A CATHETER SHAFT DAMAGE-DISTAL ISSUE OCCURRED. THE CATHETER EXHIBITED DAMAGE WHEN TAKEN OUT OF THE BOX. THE STERILMED REPROCESSED CATHETER WAS ""CHIPPED AWAY"" RIGHT BEHIND THE SECOND ELECTRODE. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS CONTINUED AND COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO DAMAGE TO THE OUTER BOX OR PACKAGING. THE DAMAGE DID NOT RESULT IN WIRES AND/OR BRAID BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THE PACKAGING WAS NOT OPENED PRIOR TO THE PROCEDURE. DEVICE EVALUATION DETAILS: ACCORDING TO PHOTO PROVIDED BY CUSTOMER, OBSERVING FROM THE TIP, THEN, BETWEEN THE SECOND AND THIRD ELECTRODE, AN ANCHOR WINDOW WAS IDENTIFIED, WHICH IS A FEATURE OF THE CATHETER. NO EXPOSED WIRES WERE OBSERVED AT THE TIP. THE PRODUCT WAS RETURNED TO STERILMED FOR EVALUATION. STERILMED PERFORMED VISUAL INSPECTION AND FUNCTIONAL TEST ON THE RETURNED DEVICE. A NON-STERILE, REPROCESSED BIOSENSE WEBSTER DIAGNOSTIC EP CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE CATHETER, VISUAL INSPECTION WAS PERFORMED, AND IT REVEALED THAT THE CATHETER WAS RETURNED WITH NO APPARENT DAMAGE. THE LOT NUMBER OF THE CATHETER INDICATED THAT IT HAD BEEN REPROCESSED ONE (1) TIME. NO PHYSICAL DAMAGE TO THE CATHETER WAS DETECTED DURING ANALYSIS. BETWEEN THE SECOND AND THIRD ELECTRODE, AN ANCHOR WINDOW WAS OBSERVED, WHICH IS A FEATURE OF THE CATHETER. NO EXPOSED WIRES WERE OBSERVED. AS PART OF STERILMED¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE DESCRIBED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE PERFORMED WITHOUT ANY PROBLEM. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. H6. INVESTIGATION FINDINGS CODE OF "APPROPRIATE TERM/CODE NOT AVAILABLE" REPRESENTS PHOTO/VIDEO ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

Additional Manufacturer Narrative

THE STERILMED PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 23-NOV-2022. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. 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 REFERENCE NUMBER: (B)(4). DURING AN INTERNAL REVIEW ON 27-NOV-2022, NOTED A CORRECTION TO THE 3500A INITIAL AS IT SHOULD HAVE STATED IN H10. ADDITIONAL MANUFACTURER NARRATIVE: 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.