BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE

    MDR report key: 18407295 · Received December 27, 2023

    Report

    Report Number
    2029046-2023-03098
    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
    DYB
    UDI-DI
    10846835016260
    PMA / PMN Number
    K170997
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROGRESS, ONCE COMPLETED A SUPPLEMENTAL 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 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 PC-(B)(4) HAS THREE REPORTS: (1) MFR # 2029046-2023-03096 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 AND SUPPLEMENTAL 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).

    Additional Manufacturer Narrative · 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. DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 00002402 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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. MANUFACTURER'S REF. # (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
    1361986 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00002402 10846835016260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L JPN CARTO 3 SYSTEM| OPTRELL, 36 ELECTRODES, D-F| SMARTABLATE GEN. KIT (JAPAN)| SOUNDSTAR ECO GE 8F CATHETER| SOUNDSTAR ECO GE 8F CATHETER| THMCL SMTCH SF BID, TC, D-F| UNK_SMARTABLATE PUMP