BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4243555 · Received November 11, 2014

    Report

    Report Number
    9673241-2014-00481
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 27, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A) THE PRODUCT WAS DISCARDED, THEREFORE, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. B) AS THE LOT # WAS PROVIDED, THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. C) CONCOMITANT BWI PRODUCTS: PRODUCT: CARTO® 3 SYSTEM, US CATALOG # FG540000J, SERIAL # (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    ON INITIAL MEDWATCH # 9673241-2014-00481 SUBMITTED ON NOVEMBER 11, 2014, ONLY THE QUANTITY OF ONE PRODUCT AND ONE LOT # WAS REPORTED WHILE IN FACT, TWO PRODUCTS WERE INVOLVED. PER EVENT DESCRIPTION: "IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE. DURING PROCEDURE, AN INCORRECT CONTACT FORCE VALUE WAS BEING DISPLAYED, ZEROING WAS CONDUCTED BUT THE ISSUE REMAINED. THE ISSUE WAS RESOLVED BY EXCHANGING THE CATHETER AND AFTERWARDS, PATIENT¿S BLOOD PRESSURE DROPPED. THE PHYSICIAN CONFIRMED PERICARDIAL EFFUSION BY AN INTRACARDIAC ECHOCARDIOGRAPHY..." THE FIRST PRODUCT USED WITH LOT # 17000931M, WHILE SECOND PRODUCT USED WITH LOT # 17000967M. BOTH PRODUCTS WILL NOT BE RETURNED SINCE THE CUSTOMER DISPOSED OF THEM. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE. DURING PROCEDURE, AN INCORRECT CONTACT FORCE VALUE WAS BEING DISPLAYED, ZEROING WAS CONDUCTED BUT THE ISSUE REMAINED. THE ISSUE WAS RESOLVED BY EXCHANGING THE CATHETER AND AFTERWARDS, PATIENT¿S BLOOD PRESSURE DROPPED. THE PHYSICIAN CONFIRMED PERICARDIAL EFFUSION BY AN INTRACARDIAC ECHOCARDIOGRAPHY. A PERICARDIOCENTESIS WAS PERFORMED WITH NO SUCCESS; THEREFORE, AN OPEN HEART SURGERY WAS CONDUCTED TO STOP BLEEDING. THIS EVENT OCCURRED DURING ABLATION PHASE. THE PROCEDURE WAS COMPLETED AND THE PATIENT DID REQUIRED HOSPITALIZATION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS UNKNOWN. THE PHYSICIAN SATED THAT EVEN NARCOTIC DOSE WAS INCREASED; ANESTHETIC CONTROL WAS NOT SUCCESSFUL THAT THE PATIENT'S BODY MOTION WAS HEAVY DURING THE PROCEDURE. SETTINGS DURING THE EVENT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727769 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-01-S 17000967M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R