BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 8609545 · Received May 14, 2019

    Report

    Report Number
    2029046-2019-03143
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 22, 2019
    Report Date
    May 16, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    UDI-DI
    10846835003154
    PMA / PMN Number
    P030031/S025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 5/14/2019, IT WAS NOTICED THAT THE PATIENT INFORMATION SUCH AS PATIENT AGE AT THE TIME OF EVENT, AGE UNIT, SEX, WEIGHT OF THE PATIENT AND WEIGHT UNIT WERE INADVERTENTLY OMITTED FROM THE 3500A INITIAL MDR TRANSMITTED TO FDA. THE FIELDS HAVE NOW BEEN POPULATED. (69-YEAR-OLD, FEMALE, WEIGHING 48 KGS.). MANUFACTURER'S REF # (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, ADDITIONAL INFORMATION WAS RECEIVED INDICATING A SMARTABLATE GENERATOR WAS USED IN THE PROCEDURE ON POWER CONTROL MODE. THE SMARABLATE GENERATOR HAS BEEN ADDED TO CONCOMITANT PRODUCTS. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30158051L NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS) AND VESSEL PERFORATION. DURING THE PROCEDURE, ONE (1) HOUR AFTER THE THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER HAD BEEN IN USE, IT WAS PLACED IN THE RIGHT VENTRICLE OUTFLOW TRACT (RVOT). IT WAS THEN NOTICED THE PATIENT¿S BLOOD PRESSURE DROPPED TO 40 UNITS. CARDIAC TAMPONADE WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. PATIENT¿S OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED. THE PHYSICIAN COMMENTED THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE BIOSENSE WEBSTER INC. (BWI) PRODUCT AND THE ADVERSE EVENT. IT WAS ALSO REPORTED THAT WHILE USING THE THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER IN THE RVOT, THE IMPEDANCE ROSE TO 300 OHMS AND THERE¿S A POSSIBILITY THAT THE PULMONARY ARTERY (PA) WAS RUPTURED AT THAT TIME. THERE IS NO INFORMATION ABOUT MEDICAL/SURGICAL INTERVENTION FOR THE VESSEL RUPTURE. NO ERROR MESSAGES WERE DISPLAYED ON ANY BWI EQUIPMENT DURING THE CASE. ALTHOUGH THE INCIDENCE OF HIGH IMPEDANCE READING OCCURRED, THERE IS NO INDICATION THAT THE IMPEDANCE EXCEEDED ANY IMPEDANCE CUT-OFF. AS SUCH, THE ISSUE OF HIGH IMPEDANCE HAS BEEN ASSESSED AS NOT MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401939 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. 30158051L 10846835003154

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R SMARTABLATE GENERATOR KIT-US