BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 6843455 · Received September 5, 2017

    Report

    Report Number
    9673241-2017-01034
    Event Type
    Injury
    Date Received
    September 5, 2017
    Date of Event
    August 8, 2017
    Report Date
    August 8, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17625817M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCT: NON BIOSENSE WEBSTER, INC. - MOBICATH 8.5F SHEATH / D140011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A LEFT VENTRICULAR OUTFLOW TRACT (LVOT) ABLATION PROCEDURE FOR IDIOPATHIC LEFT VENTRICULAR TACHYCARDIA WITH A SMARTTOUCH BIDIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. WHILE MAPPING THE LVOT NEAR THE MITRAL VALVE, PRIOR TO ANY ABLATION, THE PATIENT BECAME HYPOTENSIVE. PERICARDIAL EFFUSION WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM (ICE). PERICARDIOCENTESIS YIELDED APPROXIMATELY 200 ML OF BLOOD AND FLUID. HEPARIN WAS REVERSED PER PROTOCOL. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AS THE PATIENT WENT TO THE INTENSIVE CARE UNIT AFTER THE TAP. THE OUTCOME OF THE ADVERSE EVENT IS THAT THE PATIENT FULLY IMPROVED. THERE ARE NO KNOWN FACTORS THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. IT WAS NOTED THAT THE PHYSICIAN DOES NOT BELIEVE THE INJURY WAS A RESULT OF ANY BIOSENSE WEBSTER PRODUCT. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNKNOWN NEEDLE. THE MOBICATH 8.5FR SHEATH WAS USED. THE FLOW SETTING WAS SET AT 2 ML/MIN. HEPARIN WAS USED. ACTIVATED CLOTTING TIME WAS NOTED TO BE 276 SECONDS AT THE TIME OF INJURY. THERE WERE NO ERROR MESSAGES OBSERVED ON THE BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE SMARTTOUCH BIDIRECTIONAL CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THE SMARTTOUCH BIDIRECTIONAL CATHETER ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO® 3 PATIENT INTERFACE UNIT. THE CARTO® 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE SMARTTOUCH BIDIRECTIONAL CATHETER. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622283 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D132705 17625817M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R