BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18870809 · Received March 8, 2024

    Report

    Report Number
    2029046-2024-00786
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    February 16, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4). ON 1-APR-2024, IT WAS NOTICED THE FOLLOWING FIELDS WERE REPORTED INCORRECTLY IN THE FOLLOW-UP MEDWATCH #1: FIELD H2. IF FOLLOW-UP, WHAT TYPE? WAS REPORTED AS "DEVICE EVALUATION"; SHOULD HAVE BEEN "ADDITIONAL INFORMATION". FIELD H3. DEVICE EVALUATED BY MANUFACTURER? WAS REPORTED AS "YES"; SHOULD HAVE BEEN "DEVICE NOT RETURNED".

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL AND PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A HEARTSPAN NEEDLE. THE PATIENT'S BLOOD PRESSURE DROPPED AFTER GAINING TRANSEPTAL ACCESS. NO ABLATION HAD BEEN PERFORMED. DROP IN BLOOD PRESSURE DID NOT RESPOND TO BLOOD PRESSURE MEDICATION. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE PROCEDURE WAS ABORTED. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS UNKNOWN HOW THE INJURY OCCURRED. PATIENT HAS FULLY RECOVERED AND DID REQUIRE EXTENDED HOSPITALIZATION FOR REMOVAL OF THE PERICARDIAL DRAIN. DEVICE EVALUATION 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 00002445 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 AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL AND PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A HEARTSPAN NEEDLE. THE PATIENT'S BLOOD PRESSURE DROPPED AFTER GAINING TRANSEPTAL ACCESS. NO ABLATION HAD BEEN PERFORMED. DROP IN BLOOD PRESSURE DID NOT RESPOND TO BLOOD PRESSURE MEDICATION. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE PROCEDURE WAS ABORTED. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS UNKNOWN HOW THE INJURY OCCURRED. PATIENT HAS FULLY RECOVERED AND DID REQUIRE EXTENDED HOSPITALIZATION FOR REMOVAL OF THE PERICARDIAL DRAIN. IN THE PHYSICIAN¿S OPINION IT HAPPENED AFTER THE TRANSEPTAL. IN HIS PROTOCOL HE ASKS ANESTHESIA FOR 3 BLOOD PRESSURES FOLLOWING THE TRANSEPTAL. THESE ARE TAKEN WITH A CUFF SO SEVERAL MINUTES AFTER TRANSSEPTAL IT WAS NOTICED THAT BLOOD PRESSURE WAS NOT COMING UP. AT THAT POINT WE DID HAVE THE OCTARAY INTO THE LEFT ATRIUM. THEY THEN IMAGED THE LEFT VENTRICAL (LV) WITH ICE AND DETERMINED THEY HAD AN EFFUSION. CORRECT SETTINGS UTILIZED AND NO ERRORS ON EQUIPMENT DURING PROCEDURE. NO ABLATION OCCURRED ON THE RIGHT SIDE PRIOR TO TRANSSEPTAL PUNCTURE TO THE LEFT SIDE OF THE HEART. THE MOST SUSPECTED DEVICES CAUSING THE ADVERSE EVENT ARE THE DEVICES USED FOR TRANSSEPTAL PUNCTURE. CLINICAL ASSUMPTION IS THAT THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL WAS USED FOR TRANSSEPTAL PUNCTURE. THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL WAS MANIPULATED THROUGH TO THE LEFT SIDE AFTER TRANSSEPTAL PUNCTURE, AS SUCH, IT CANNOT BE COMPLETELY DISSOCIATED AS A CONTRIBUTOR TO THE EVENT AND REMAINS TO BE A SUSPECTED DEVICE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696251 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00002445 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Life Threatening| R CARTO 3 SYSTEM.| HEARTSPAN NEEDLE.| NGEN RF GENERATOR, JAPAN.| OCTA,LNG,48P,3-3-3-3-3,D-CURVE.| QDOT MICRO, BI, TC, D-F.