BEUDAMED
    FDA Adverse Event Death Summary report: N

    Z-5 ATRIOSEPTOSTOMY

    MDR report key: 9403570 · Received December 3, 2019

    Report

    Report Number
    9618000-2019-00009
    Event Type
    Death
    Date Received
    December 3, 2019
    Date of Event
    October 30, 2019
    Report Date
    December 3, 2019
    Manufacturer
    NUMED CANADA, INC.
    Product Code
    DXF
    PMA / PMN Number
    K960070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE REPORT FROM THE USER FACILITY/DISTRIBUTOR, IT STATED THAT THEY USED 5ML OF CONTRAST MEDICA TO INFLATE THE BALLOON. THIS BALLOON IS ONLY RATED FOR 1CC, SO THEY INFLATED IT WITH 5 TIMES WHAT IT IS RATED FOR. THERE IS A WARNING STATEMENT IN THE IFU THAT SAYS - CAUTION: DO NOT EXCEED THE RATED VOLUME OF 1CC FOR THE SPT002 - 9.5MM CATHETER. OVER INFLATION MAY CAUSE BALLOON RUPTURE. THERE IS ALSO A CAUTION THAT STATES - " THE USE OF EXCESSIVE FORCE TO PULL THE BALLOON ACROSS THE ATRIAL SEPTUM MUST BE AVOIDED. SPECIFICALLY, THE PHYSICIAN SHOULD AVOID USING THE ENTIRE ARM WHEN PULLING THE BALLOON ACROSS THE SEPTUM AND SHOULD INSTEAD USE ONLY THE MOTION OF THE WRIST. IF THE BALLOON DOES NOT EASILY CROSS THE SEPTUM USING THIS METHOD, IT IS RECOMMENDED THAT A SMALLER VOLUME OF FLUID BE USED INITIALLY. THE AMOUNT OF FLUID CAN THEN BE GRADUALLY INCREASED IN VOLUME UNTIL THE DESIRED RESULT IS ACHIEVED. IF THE FIRST TWO STEPS ARE NOT SUCCESSFUL, CONSIDER STATIC BALLOON DILATION OF THE ATRIAL SEPTUM." ACCORDING TO THE IFU, THE 9.5MM BALLOON IS PRIMARILY USED FOR INFANTS LESS THAN 2KG. THIS PATIENT WAS 5KG. THE DEVICE HISTORY RECORD WAS REVIEWED AND THE DEVICES MET ALL CRITERIA FOR RELEASE. THERE HAVE BEEN 784 PIECES OF THIS TUBING MATERIAL ISSUED AND USED ON OTHER DEVICES. THERE HAVE NO OTHER COMPLAINTS ON THIS TUBING MATERIAL. TWO REJECTED COMPARATIVE CATHETERS WERE PULLED FOR TESTING. THE COMPARATIVE CATHETERS WERE FROM THE SAME LOT AS THE COMPLAINT DEVICE (AS-2281). THE FIRST CATHETER WAS LOADED INTO THE SPECIAL TEST FIXTURE (INSTRON) AND PULL TESTED IN A MANNER SIMILAR TO THAT WHICH WAS USED FOR THE ORIGINAL BENCH TESTING OF THIS CATHETER MODEL FOR THE REGULATORY SUBMISSIONS. THE SHAFT FAILED WITH A PULL FORCE OF 8.15 LBF., WHICH IS EQUAL TO 36.26 NEWTONS. THIS VALUE EXCEEDS THE ACCEPTANCE CRITERIA (8.9 NEWTONS) THAT WAS USED FOR THE ORIGINAL BENCH TESTING AS WELL AS THE ACTUAL RESULTS OF THE BENCH TESTING (RANGE 31.1-40.0 NEWTONS, AVERAGE 35.6 NEWTONS, STD.DEV. 4.448). THE SECOND CATHETER WAS LOADED INTO THE INSTRON AND PULL TESTED IN THE SAME MANNER AS THE FIRST TEST. THE SHAFT FAILED WITH A PULL FORCE OF 6.88 LBF., WHICH IS EQUAL TO 30.62 NEWTONS. THIS VALUE EXCEEDS THE ACCEPTANCE CRITERIA (8.9 NEWTONS).

    Description of Event or Problem · 1

    INCIDENT DESCRIPTION FROM THE PHYSICIAN / USER FACILITY: THE PATIENT WAS ADMITTED FOR THE CATE D + RASHKIND GUIDED BY TRANSTHORACIC ECHOCARDIOGRAM PROCEDURE. THE PROCEDURE WAS CARRIED OUT UNDER GENERAL ANESTHESIA, BY VFD 7F, USING 5 ML OF CONTRAST. THE GUIDE WIRE 0.014" WAS POSITIONED IN THE PULMONARY VEIN. DURING ATRIOSEPTOSTOMY MANEUVER WITH NUMED Z-5 9,5 MM BALLOON THERE WAS BREAKAGE OF THE BALLOON CATHETER. THE CATHETER WAS WITHDRAWN AND THE BALLOON REMAINED INSIDE THE LEFT ATRIUM. IT WAS BROUGHT TO THE RIGHT ATRIUM AND MIGRATE TO THE RIGHT VENTRICLE. IT WAS PERFORMED MANY ATTEMPTS OF WITHDRAW WITH LASSO AND BIOTOME WITHOUT SUCCESS. THE CASE WAS DISCUSSED WITH THE PHYSICIANS PAULA AND CARLA AND WAS DECIDED TO REMOVE THE BALLOON SURGICALLY. THE PATIENT WAS FORWARDED TO CC WITH ADRENALINE 0.05 MCG/KG/MIN, UNDER IOT + VM. PAP 80 MMHG SPO2 81% IT WAS PASSED A DOUBLE LUMEN CENTRAL VENOUS CATHETER 5F IN VFD AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200404 Z-5 ATRIOSEPTOSTOMY ATRIOSEPTOSTOMY CATHETER DXF NUMED CANADA, INC. 210 AS-2281

    Patients

    Seq Age Sex Outcome Treatment
    1 2 WK Death