BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE

    MDR report key: 15993360 · Received December 15, 2022

    Report

    Report Number
    2029046-2022-03142
    Event Type
    Injury
    Date Received
    December 15, 2022
    Date of Event
    November 17, 2022
    Report Date
    January 28, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835000047
    PMA / PMN Number
    K982740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED ON 28-JAN-2023 SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 18126833 NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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 · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN AT - RIGHT ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE. THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS NOTICED ON CONTRAST USING FLUOROSCOPY AFTER THE EP STUDY WAS PERFORMED AND BEFORE ANY MAPPING OR ABLATION HAD BEGUN. THE PHYSICIAN SAW THE CONTRAST DISPLAYED ON FLUOROSCOPY IN THE SHELL OF THE RIGHT VENTRICLE (RV) INSTEAD OF THE CORONARY SINUS (CS) WHERE IT WAS SUPPOSED TO BE. THE PHYSICIAN THINKS THAT A PERFORATION OF THE RV HAD OCCURRED. THE PATIENT¿S BLOOD PRESSURE HAD STARTED DECREASING "A LITTLE BIT." THE PERICARDIAL EFFUSION WAS CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE ANESTHESIOLOGY ADMINISTERED DRUGS FOR BLOOD PRESSURE SUPPORT AND THE PHYSICIAN ATTEMPTED TO PERFORM A PERICARDIOCENTESIS BUT WAS UNABLE TO DO SO. AN INTERVENTIONAL CARDIOLOGIST WAS CALLED TO PERFORM THE PERICARDIOCENTESIS AND ALMOST 500 CC'S OF FLUID WERE REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE FOLLOWING BWI PRODUCTS WERE INSIDE THE PATIENT: PENTARAY NAV ECO 7FR, F, 2-6-2, ICE CATHETER, AND A VIZIGO SHEATH. IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED. ADDITIONAL INFORMATION WAS RECEIVED. PRODUCT INFORMATION FOR ICE CATHETER WAS THE SOUNDSTAR ECO GE 10F CATHETER. THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE WAS USED AND NOT THE VIZIGO SHEATH. THE ADVERSE EVENT WAS DISCOVERED AFTER GROIN ACCESS OBTAINED AND SOUND CONTOURS DRAWN BUT PRIOR TO TRANSSEPTAL, MAPPING, AND ABLATION. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THE MD SUSPECTED THE RV WAS PERFORATED WHEN HE WAS TRYING TO PERFORM A VEIN OF MARSHALL ALCOHOL ABLATION. PER MD, NOT SURE IF IT WAS THE SHEATH OR THE QUAD BUT CONTRAST WAS SHOT STRAIGHT INTO THE RV, NO CS CONTRAST VISIBLE ON X-RAY. ANESTHESIA HAD FLUIDS AND MEDICATION RUNNING "WIDE OPEN". MD ATTEMPTED TO PERFORM A PERICARDIOCENTESIS BUT WAS UNABLE TO GET WIRE TO WHERE IT NEEDED TO GO. INTERVENTIONAL CARDIOLOGY WAS CALLED IN TO ASSIST WHERE HE WAS ABLE TO PULL APPROXIMATELY 500ML OF FLUID OUT OF THE PERICARDIAL SPACE. OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). ABLATION ABORTED, PATIENT WAS STABLE AND WENT TO CVOR FOR OBSERVATION. INITIAL PLAN WAS TO SEND PATIENT HOME AFTER A FEW HOURS OF OBSERVATION. UNKNOWN IF PATIENT WAS ADMITTED OVERNIGHT OR HAD ANY LONG-STANDING ISSUES DUE TO PERICARDIAL EFFUSION. OTHER RELEVANT HISTORY-SECOND ABLATION. NO TRANSSEPTAL PUNCTURE PERFORMED. ABLATION WAS NOT PERFORMED PRIOR TO NOTING THE CARDIAC TAMPONADE. NO EVIDENCE OF STEAM POP. EVENT OCCURRED PRIOR TO ALL PHASES. PATIENT WAS UNDER GENERAL ANESTHESIA FOR ABOUT 4 HOURS. THE QUAD CATHETER WAS AN ABBOTT SUPREME. THE MD ONLY USES THEM TO VISUALIZE WITH FLUOROSCOPY. IT DOES NOT GET PLUGGED INTO CARTO/RECORDING SYSTEM. IT WAS NOT SAVED. PER THE MD¿S COMMENT ABOUT THE SUSPICION OF THE RV PERFORATING WHEN HE WAS TRYING TO PERFORM A VEIN OF MARSHALL ALCOHOL ABLATION AND WAS NOT SURE IF IT WAS THE SHEATH OR THE QUAD BUT CONTRAST WAS SHOT STRAIGHT INTO THE RV AND NO CS CONTRAST VISIBLE ON X-RAY, THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439534 PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 301803M 18126833 10846835000047

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening| R NON BWI-ABBOTT SUPREME QUAD CATHETER.| PENTARAY NAV ECO 7FR, F, 2-6-2.| SOUNDSTAR ECO GE 10F CATHETER.| UNKNOWN BRAND RECORDING SYSTEM.| UNK_CARTO 3.