BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR RMT THERMOCOOL CATHETER

    MDR report key: 11718508 · Received April 23, 2021

    Report

    Report Number
    2029046-2021-00658
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    April 9, 2021
    Report Date
    April 9, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    UDI-DI
    10846835008500
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE ((B)(6) KG) PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT)ABLATION PROCEDURE WITH A NAVISTAR¿ RMT THERMOCOOL¿ CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING A PVC CASE, A CARDIAC TAMPONADE WAS NOTICED. THERE WAS A DROP IN BLOOD PRESSURE AND AN INCREASE IN HEART RATE ON THE PATIENT. THE PERFORATION WAS CONFIRMED BY TRANSTHORACIC ECHO. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 3-4 LITERS OF FLUID WAS REMOVED AND AUTO TRANSFUSED. THE PATIENT WAS THEN TAKEN INTO SURGERY FOR A FULL STERNOTOMY TO REPAIR A PERFORATION IN THE LEFT VENTRICLE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIANS OPINION ON THE CAUSE OF THIS ADVERSE EVENT: BWI PRODUCT MALFUNCTION  NO; PROCEDURE  YES; PATIENT CONDITION  NO. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED (NO RESIDUAL EFFECTS). TRANSSEPTAL PUNCTURE WAS NOT PERFORMED AND ABLATION WAS PERFORMED PRIOR TO NOTING CARDIAC TAMPONADE. THERE WAS EVIDENCE OF A STEAM POP. IRRIGATION CATHETER WAS USED IN THE EVENT, THE FLOW SETTING 30ML/MIN. THERE WERE NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. VISITAG MODULE WAS USED, WHAT PARA METERS FOR STABILITY WERE USED: 3MM, 5SEC, RESP GATED AND NO ADDITIONAL FILTER USED WITH THE VISITAG. COLOR OPTIONS WERE USED PROSPECTIVELY: IMPEDANCE DROP 0-10 OHMS. SINCE THIS EVENT IS LIFE-THREATENING AND REQUIRED INTERVENTIONS TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, THEN IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609696 NAVISTAR RMT THERMOCOOL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC NR7TCSIY 10846835008500

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R