BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUCLEUS CATHETER

    MDR report key: 19135533 · Received April 18, 2024

    Report

    Report Number
    9618000-2024-00002
    Event Type
    Death
    Date Received
    April 18, 2024
    Date of Event
    March 22, 2024
    Report Date
    April 18, 2024
    Manufacturer
    NUMED CANADA, INC.
    Product Code
    OZT
    PMA / PMN Number
    K082776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO ISSUES WERE NOTED. THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER OF DEVICES. A REVIEW WAS ALSO PERFORMED ON THE BALLOON TUBING USED TO MANUFACTURE THESE BALLOONS. NO OTHER COMPLAINTS WERE ASSOCIATED WITH THE TUBING USED TO MANUFACTURE THE BALLOONS. THE COMPLAINT CATHETER WAS NOT RETURNED SO THE COMPLAINT COULD NOT BE CONFIRMED. CLARIFICATION WAS NEEDED AS THE REPORT CONTAINED INFORMATION THAT WAS NOT CLEAR. INITIAL COMPLAINT STATED THAT THE BALLOON BROKE INTO TWO PIECES AND ONE PIECE WAS LEFT IN THE PATIENT. CLARIFICATION WAS LATER RECEIVED THAT NO PART OF THE DEVICE WAS LEFT IN THE PATIENT. INITIAL COMPLAINT STATED THAT THEY PHYSICIAN USED VOLUME TO INFLATE THE DEVICE RATHER THAN PRESSURE AS REQUIRED IN THE INSTRUCTIONS FOR USE BY THE MFTR. IT WAS UNKNOWN AS TO WHAT VOLUME THE PHYSICIAN USED. CLARIFICATION WAS RECEIVED FROM THE PHYSICIAN THAT AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED, HOWEVER THE PROCESS WAS MODIFIED. INITIAL COMPLAINT STATED THEY TRIED TO IMPLANT A MEDTRONIC VALVE FIRST AND IT FAILED. THEN THE BALLOON CATHETER WAS USED AND BURST. CLARIFICATION WAS RECEIVED THAT THE VALVE WAS PRE-DILATED WITH THE NUCLEUS CATHETER. THE PATIENT HAD THE PRE-EXISTING CONDITION OF SEVERE AORTIC ATHEROMA. WHEN THE BALLOON BURST, IT CREATED AN "UMBRELLA" AND THE REMOVAL WAS COMPLICATED BY A MAJOR EMBOLIZATION OF THE ATHEROMA ORIGINATING IN THE AORTA. THERE WERE MULTIPLE EMBOLIZATIONS (CEREBRAL, CUTANEOUS OF THE 2 LOWER LIMBS, MOST CERTAINLY RENAL IN VIEW OF THE SEVERE ACUTE RENAL FAILURE). AFTER THE BALLOON BURST THE PHYSIAN TRIED TO IMPANT THE MEDTRONIC EVOLUT PRO+ VALVE THAT FAILED DUE TOFAILURE TO CROSS DUE TO A VERTICAL RING. THE PHYSICAN THEN IMPLANTED THE SAPIEN 3 VALVE. PHYSICIAN STATED THAT THE COMPLETE LEFT BUNDLE BRANCH BLCOK HAPPENED AFTER IMPLANTATION OF THE SAPIEN 3 VALVE. NUMED COULD NOT CONFIRM THE BALLOON BURST DUE TO THE DEVICE NOT BEING RETURNED AND NO PICTURES WERE PROVIDED. A COMPARATIVE CATHETER WAS PULLED AND TESTED FOR RATED BURST PRESSURE. THE COMPARATIVE CATHETER WAS THE SAME CATALOG NUMBER BUT A DIFFERENT LOT NUMBER AS THE COMPLAINT CATHETER. THE BALLOON MATERIAL COMPONENT LOT USED ON THE COMPLAINT CATHETER WAS THE SAME AS THE BALLOON MATERIAL COMPONENT LOT AS THE COMPARATIVE CATHETER. THE BALLOON WAS IMMERSED IN A BODY TEMPERATURE BATH AND INCREMENTALLY INFLATED UNTIL IT BURST. THE FIRST BALLOON DID NOT BURST UNTIL 7.0 ATM, WHICH IS WELL ABOVE THE LABELED RATED BURST PRESSURE OF 4.0 ATM FOR THIS CATALOG NUMBER. THE COMPLAINT COULD NOT BE DUPLICATED WITH THE COMPARATIVE CATHETER WHEN TAKEN TO THE LABELED RATED BURST PRESSURE. THE BALLOON HAD TO BE OVER PRESSURIZED TO ALMOST DOUBLE THE LABELED RATED BURST PRESSURE BEFORE IT BURST. WHEN BURST OCCURRED IT WAS IN A LONGITUDINAL DIRECTION. BASED ON HISTORICAL DATA, MOST BALLOON BURSTS ARE CAUSED BY OVER PRESSURIZATION OF THE BALLOON THAT IS DONE QUICKLY. AS PER THE USER FACILITY / DISTRIBUTOR, THEY WERE NOT MONITORING THE BALLOON FOR PRESSURE BUT WERE USING VOLUME INSTEAD TO INFLATE THE BALLOON. THIS IS NOT WHAT NUMED RECOMMENDS IN THE INSTRUCTIONS FOR USE. THERE IS A WARNING IN THE INSTRUCTIONS FOR USE THAT STATES: WARNING - DO NOT EXCEED THE RBP. AN INFLATION DEVICE WITH PRESSURE GAUGE IS RECOMMENDED TO MONITOR PRESSURE. PRESSURE IN EXCESS OF THE RBP CAN CAUSE BALLOON RUPTURE AND POTENTIAL INABILITY TO WITHDRAW THE CATHETER THROUGH THE INTRODUCER SHEATH.

    Description of Event or Problem · 0

    PATIENT TREATED FOR TAVI PLACEMENT ON (B)(6), PLACEMENT OF A "SAPIENS 3 EDWARDS" VALVE S3UCM326 LOT 11092712 AFTER FAILURE OF THE PLACEMENT OF A MEDTRONIC EVOLUT PRO+ VALVE (FAILURE TO CROSS) REF EVPROPLUS29 LOT J137714. PRE-DILATATION PROCEDURE OF THE CALCIFIED RIGHT ATRIUM (RA). TRANSVERSE RUPTURE OF NUCLEUS BALLOON AND SHAFT : BALLOON BREAK IN TWO PIECES, ALL PIECES REMOVED FROM THE PATIENT. THE INITIAL NOTIFICATION PROCEDURE WAS CLASSIFIED AS COMPLEX. COMPLETE LEFT BUNDLE BRANCH BLOCK AFTER IMPLANTATION. MONITORING, BOTH NEUROLOGICAL AND EMBOLIC. MULTIVISCERAL EMBOLISATION (STROKE, KIDNEY, LIVER, SKIN). PATIENT HAD SEVERE AORTIC ATHEROMA PRIOR TO PROCEDURE. DEATH PRONOUNCED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606894 NUCLEUS CATHETER AORTIC VALVULOPLASTY CATHETER OZT NUMED CANADA, INC. 230 Y-10319

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Female Death