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Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A REPROCESSED DYNAMIC XT STEERABLE DECAPOLAR CATHETER AND IT APPEARED LIKE THE PACKAGING WAS CONTAMINATED. SPECK OF WHAT APPEARS TO BE BLOOD WAS NOTICED. A NON-STERILE REPROCESSED BARD DYNAMIC XT STEERABLE DECAPOLAR LARGE CURVE EP CATHETER, BAR201101, WAS RECEIVED CONTAINED AND COILED INSIDE A RESEALABLE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS CONDUCTED, AND IT REVEALED THAT THE CATHETER WAS RETURNED WITH NO APPARENT DAMAGE. THERE WAS NO OBSERVED FOREIGN MATTER ON THE RETURNED DEVICE. THE DEVICE, SERIAL NUMBER 2504100129, HAD BEEN REPROCESSED TWO (2) TIMES, MOST RECENTLY UNDER LOT 2237735. THE PRIMARY PACKAGING WAS RETURNED FOLDED WITHIN A RESEALABLE BAG. THE INTERIOR BACKING BOARD WAS NOT RETURNED. THE CHEVRON SIDE WAS PULLED APART, AS DEVICE WAS REMOVED FROM THE PACKAGE. IT WAS OBSERVED THAT THERE WERE TWO BLACK PEN CIRCLES THAT ENCOMPASSED WHAT IS OBSERVED AS SCUFF MARKS AND SURFACE ABRASIONS ON THE EXTERIOR OF THE PACKAGING. AN OBJECT HAD RUBBED AGAINST THE EXTERIOR OF THE PACKAGE, LEAVING INDENTATIONS ON THE PACKAGE SURFACE, WHICH COULD APPEAR AS UNCLEAN. WHEN THIS OCCURRED, COULD NOT BE DETERMINED. NO OTHER PHYSICAL DAMAGE WAS NOTED ON THE PACKAGING. THE REMAINDER OF THE PACKAGING WAS EXAMINED AND THERE WERE NO OBSERVATIONS OF ANY FOREIGN MATERIAL INSIDE THE PACKAGE. FOREIGN MATTER INSIDE THE PACKAGING WAS NOT CONFIRMED. WHAT IS OBSERVED IS NOT FOREIGN MATTER OR CONTAMINATION, BUT DAMAGE TO THE OUTSIDE (EXTERIOR) OF THE PRIMARY PACKAGE. AS PART OF STERILMED¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ALTHOUGH NO FOREIGN MATTER WAS IDENTIFIED ON THE INTERIOR OF THE PACKAGING, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES, SUCH AS DEVICE/PACKAGE HANDLING AND STORAGE THAT COULD CONTRIBUTE TO THE PACKAGING¿S EXTERIOR APPEARANCE, THOUGH THE EXACT CAUSE CANNOT BE DETERMINED. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED AND THERE WERE NO IDENTIFIED INTERNAL ACTIONS RELATED TO THE LOT OR REPORTED ISSUE. H6 CODES C19 AND D14 ARE FOR THE CONTAMINATION ISSUE THAT WAS NOT CONFIRMED. 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. 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 AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A REPROCESSED DYNAMIC XT STEERABLE DECAPOLAR CATHETER AND IT APPEARED LIKE THE PACKAGING WAS CONTAMINATED. SPECK OF WHAT APPEARS TO BE BLOOD WAS NOTICED. THE NURSE OPENED THE OUTER PACKAGING WITH NEW GLOVES AND THE PHYSICIAN NOTICED THE DRIED BLOOD ON THE INNER PACKAGING WHEN HE WENT TO GRAB IT WITH CLEAN GLOVES. NEITHER HAD BLOOD ON THEIR GLOVES AND THE PHYSICIAN STATED HE SAW IT IMMEDIATELY AS IT WAS HANDED TO HIM. NO OTHER PHYSICAL DAMAGE WAS NOTED ON THE PACKAGING. THERE WAS NO PATIENT INJURY OR CONSEQUENCE.