BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18406670 · Received December 27, 2023

    Report

    Report Number
    2029046-2023-03096
    Event Type
    Injury
    Date Received
    December 27, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 27, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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. E1. INITIAL REPORTER PHONE: (B)(6). 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 THREE REPORTS: . FOR PRODUCT CODE D134805 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER) (2) MFR # 2029046-2023-03097 FOR PRODUCT CODE D142901 (OPTRELL MAPPING CATHETER). (3) MFR # 2029046-2023-03098 FOR PRODUCT CODE D138503 (CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE).

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** CORRECTION TO THE INITIAL MDR, INCOMPLETE UDI WAS PROVIDED. SECTION D4. PRIMARY UDI NUMBER HAS BEEN UPDATED WITH FULL UDI (B)(4). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. TRANSSEPTAL PUNCTURE WAS PERFORMED. THEN DURING OPTRELL MAPPING, ABOUT 2 HOURS AFTER THE START OF THE PROCEDURE, CARDIAC MOTION BECAME SLOW AND TAMPONADE WAS CONFIRMED. ABOUT 70 CC OF DRAINAGE WAS TAKEN, AND THEN HEART MOVEMENT RETURNED, AND THE PATIENT RETURNED TO THE WARD. AFTER THE PROCEDURE, BLEEDING FROM THE TAMPONADE AREA SUBSIDED. THE PROCEDURE WAS COMPLETED. ABLATION WAS NOT PERFORMED BEFORE PERICARDIAL EFFUSION OR TAMPONADE WAS IDENTIFIED. STEAM POP WAS NOT OBSERVED. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WERE, ONE POSSIBILITY WAS THAT THE RIGHT VENTRICLE(RV) CATHETER THAT WAS PLACED DURING PULMONARY ANGIOGRAM (PA) WAS IN THE BACK OF THE RIGHT VENTRICLE. ANOTHER POSSIBILITY WAS CONSIDERED IN TWO PATTERNS BECAUSE PULMONARY ANGIOGRAM THE CONTACT FORCE (CF) WAS TEMPORARILY ELEVATED WHEN THE COMBINATION OF THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE AND THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS INSERTED INTO THE LV (LEFT VENTRICLE). NO ABNORMALITIES OBSERVED DURING USE OF THE PRODUCT. PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274899 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31079948L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R 8.5F SHEATH WITH CURVE VIZ LGC| JPN CARTO 3 SYSTEM| OPTRELL, 36 ELECTRODES, D-F| SMARTABLATE GEN. KIT (JAPAN)| SOUNDSTAR ECO GE 8F CATHETER| SOUNDSTAR ECO GE 8F CATHETER| UNK_SMARTABLATE PUMP