BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 18545310 · Received January 19, 2024

    Report

    Report Number
    2029046-2024-00236
    Event Type
    Injury
    Date Received
    January 19, 2024
    Date of Event
    December 22, 2023
    Report Date
    April 17, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021141
    PMA / PMN Number
    K193237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON 19-JAN-2024, THE CODE OF SURGICAL INTERVENTION (F19) WAS ADDED. THEREFORE, THE H 6. HEALTH EFFECT - IMPACT CODE HAS BEEN UPDATED. 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 · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED WHICH INCLUDED PERFORMING A MANUFACTURING RECORD EVALUATION (MRE). THE MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31124100L NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. ADDITIONALLY, THE MANUFACTURE AND EXPIRATION DATES HAVE BEEN PROVIDED. THEREFORE, FIELDS D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MFR # 2029046-2024-00235 FOR PRODUCT CODE D134805 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER) (2) MFR # 2029046-2024-00236 FOR PRODUCT CODE D160901 (OCTARAY MAPPING CATHETER).

    Additional Manufacturer Narrative · 0

    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. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MFR # 2029046-2024-00235 FOR PRODUCT CODE D134805 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER). (2) FOR PRODUCT CODE D160901 (OCTARAY MAPPING CATHETER).

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT AN ATRIAL FIBRILLATION CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND AN OCTARAY MAPPING CATHETER. THE PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS AND SURGERY WITH PROLONGED HOSPITALIZATION.DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PATIENT WAS ON THE TABLE UNDER GENERAL ANESTHESIA, PHYSICIAN SCRUBBED IN, AND DIAGNOSTIC, ULTRASOUND AND THERAPEUTIC CATHETERS WERE INSERTED INTO THE PATIENT¿S HEART. AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) GUIDED ABLATION OF THE CAVO TRICUSPID ISTHMUS WITH THE THERMOCOOL SMARTTOUCH DF ABLATION CATHETER WAS COMPLETED ON THE RIGHT SIDE OF THE HEART, DURING WHICH NO STEAM POPS, NO HIGH IMPEDANCE OR HIGH FORCE OUTSIDE OF NORMAL RANGE WAS OBSERVED.A POWER OF 35 W WAS USED WITH A TEMP CUT-OFF OF AT 40 DEGREES AND IMPEDANCE CUT-OFF OF AT 250 OHMS. TRANSEPTAL ACCESS WAS THEN COMPLETED UNDER ICE GUIDANCE WITH THE 8FR SOUNDSTAR CATHETER. AT THIS POINT, IT WAS CONFIRMED ON THE ICE IMAGE THAT THERE WAS NO PRE-EXISTING EFFUSION PRESENT. THE THERMOCOOL SMARTTOUCH ABLATION AND THE OCTARAY MAPPING CATHETERS WERE THEN ADVANCED INTO THE LEFT ATRIUM WHERE A LEFT ATRIAL MAP WAS COMPLETED USING THE OCTARAY CATHETER. PRIOR TO ABLATION ON THE RIDGE OF THE LEFT ATRIUM, THE ICE IMAGE WAS RE-POSITIONED TO VISUALIZE THIS ANATOMICAL AREA, AT WHICH POINT A LARGE PERICARDIAL EFFUSION WAS OBSERVED. THE PHYSICIAN THEN PERFORMED A PERICARDIAL TAP TO DRAIN THE BLOOD, THROUGHOUT WHICH MONITORING THE EFFUSION LIVE ON ICE. THE EFFUSION RESOLVED AND THE PATIENT¿S BLOOD PRESSURE STABILIZED. THE PULMONARY VEIN ISOLATION WAS ABORTED TO ALLOW THE PATIENT TO RECOVER AND CONTINUE TO BE MONITORED. THE PHYSICIAN INDICATED THEY DID NOT BELIEVE THE EFFUSION OCCURRED AS A RESULT OF USE WITH A BIOSENSE WEBSTER PRODUCT.ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT REQUIRED CARDIAC SURGERY TO SUTURE A SMALL HOLE IN THE LEFT ATRIAL APPENDAGE. PATIENT HAS FULLY RECOVERED BUT REQUIRED EXTENDED HOSPITALIZATION (STAYED FOR MONITORING POST SUTURE REPAIR).ABLATION WAS PERFORMED TO THE RIGHT ATRIUM ONLY PRIOR TO TRANSSEPTRAL ACCESS. THE EVENT OCCURRED DURING TRANSSEPTAL / LEFT ATRIUM (LA) MAPPING PHASE. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141296 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31124100L 10846835021141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H| L ABBOTT MEDICAL ¿ BRK TRANSSEPTAL NEEDLE| ABBOTT REPROCESSED AGILIS SHEATH| ABBOTT REPROCESSED SL1 SHEATH| REPROCESS SDSTR ECO 8F-90 SMS| SMARTABLATE GENERATOR KIT-WW| SMARTABLATE PUMP KIT-WW| THMCL SMTCH SF BID, TC, D-F| UNK_CARTO 3