BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 10367755 · Received August 5, 2020

    Report

    Report Number
    2029046-2020-00997
    Event Type
    Injury
    Date Received
    August 5, 2020
    Date of Event
    July 9, 2020
    Report Date
    July 9, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, BIONSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE CS CATHETER THAT WAS USED DURING THE PROCEDURE WAS A BEEAT CS CATHETER BY JAPAN LIFE LINE (JLL). AS SUCH, THE DEVICE HAS BEEN ADDED TO FIELD D11. CONCOMITANT MED. PRODUCTS. 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 · 1

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE WITH LOT NUMBER 30360816M, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. 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 PATIENT ((B)(6) KG) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER THE PROCEDURE WAS COMPLETED THE PATIENT¿S BLOOD PRESSURE DROPPED, AND PERICARDIAL FLUID WAS CONFIRMED BY ECHOCARDIOGRAPHY. PERICARDIOCENTESIS WAS PERFORMED TO DRAIN AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. IT IS UNKNOWN IF PROLONGED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME WAS NOT PROVIDED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED, THE PHYSICIAN COMMENTED THAT IT IS POSSIBLE THAT THE RIGHT ATRIUM WAS DAMAGED WHEN INSERTING THE CORONARY SINUS (CS). NO BIOSENSE WEBSTER PRODUCT MALFUNCTIONS NOR ERROR MESSAGES WERE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834598 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134801 30360816M 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R BEEAT CS CATHETER BY JAPAN LIFE LINE