EP CATHETER WEBSTER LASSO® 2515 ECO VARIABLE CATHETER

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH AN EP CATHETER WEBSTER LASSO® 2515 ECO VARIABLE CATHETER AND A CONTRACTION STUCK ISSUE OCCURRED. THE DEVICE EVALUATION WAS COMPLETED ON 02-MAY-2023. A NON-STERILE REPROCESSED LASSO® 2515 ECO VARIABLE WAS RETURNED IN THE DECONTAMINATION BAG. UPON RECEIPT OF THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND NO APPEARANCE OF DAMAGE WAS OBSERVED. ACCORDING TO THE DEVICE HISTORY, THE CATHETER HAD BEEN REPROCESSED ONE (1) TIME. THE CONTRACTION AND DEFLECTION MECHANISMS WERE TESTED. THE CONTRACTION MECHANISM WAS CONFIRMED TO BE WORKING CORRECTLY, THE HANDLE WAS ROTATED CLOCKWISE, AND NO CLICKING WAS HEARD, THE MINIMUM DIAMETER OF 15 MM WAS ATTAINED. THE HANDLE WAS ROTATED COUNTER-CLOCKWISE, AND THERE WAS NO RESISTANCE WHILE OPENING THE LOOP, THE MAXIMUM DIAMETER OF 25 MM WAS ATTAINED. THE DEFLECTION CURVE WAS ALSO CONFIRMED TO MEET THE SPECIFICATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS NO PRODUCT MALFUNCTION WAS IDENTIFIED, THE RETURNED CATHETER WOULD BE EXPECTED TO WORK ACCORDING TO THE RELEASE CRITERIA. 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 IN THE LABORATORY SETTING. THE INSTRUCTIONS FOR USE (IFU) PROVIDES PROPER HANDLING INSTRUCTIONS TO PREVENT ISSUES SUCH AS CONTRACTION ISSUES FROM OCCURRING. TO AVOID POTENTIAL DAMAGE TO ANATOMICAL STRUCTURES, DO NOT ATTEMPT TO PULL THE CATHETER, OR WITHDRAW IT INTO THE SHEATH, WITH THE LOOP IN A CONTRACTED POSITION. THE LOOP SHOULD BE FULLY RELAXED (HANDLE GRIP ROTATED FULLY TO THE LEFT) TO MINIMIZE TENSION APPLIED TO THE NITINOL STRUCTURE. AS PART OF STERILMED¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 25-APR-2023. 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).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH AN EP CATHETER WEBSTER LASSO® 2515 ECO VARIABLE CATHETER AND A CONTRACTION STUCK ISSUE OCCURRED. DURING THE PROCEDURE, THE EP CATHETER WEBSTER LASSO® 2515 ECO VARIABLE CATHETER WAS INSERTED INTO LEFT ATRIUM. WHILE MANEUVERING THE CATHETER AND ATTEMPTING TO OPEN AND CLOSE THE EP CATHETER WEBSTER LASSO® 2515 ECO VARIABLE CATHETER LOOP TO CREATE THE LEFT ATRIAL ANATOMY, THE CATHETER WOULD CLICK WHEN CLOSING THE LOOP, CREATING RESISTANCE TO OPEN THE LOOP AGAIN. PHYSICIAN PULLED THE CATHETER OUT OF THE PATIENT AND INSPECTED THE CATHETER TO CONFIRM FAULTY MECHANISM. SINCE SOME OF THE LEFT ATRIAL ANATOMY WAS ALREADY CREATED, PHYSICIAN CONTINUED TO MAP USING THE ABLATION CATHETER. THE PROCEDURE CONTINUED WITH NO ADVERSE EVENT. THE PROCEDURE WAS NOT DELAYED. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A CONTRACTION STUCK ISSUE.

Additional Manufacturer Narrative

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 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).