BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6084529 · Received November 7, 2016

    Report

    Report Number
    9673241-2016-00767
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 14, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. 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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED. CONCOMITANT PRODUCTS: WEBSTER CORONARY SINUS WITH AUTO ID CATHETER: MODEL #: D-1353-03-S, LOT #: UNKNOWN. SOUNDSTAR ECO CATHETER: MODEL #: M-5723-18 LOT #: UNKNOWN. CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #: (B)(4). SMART ABLATE GENERATOR: MODEL #: M-4900-07, SERIAL #: (B)(4). SMART ABLATE PUMP: MODEL #: M-4900-08, SERIAL #: (B)(4). DISTRIBUTED - HEARTSPAN TRANSEPTAL NEEDLE: MODEL #: D-1348-05-S, LOT #: UNKNOWN. DISTRIBUTED - MOBICATH: MODEL #: D-1400-10, LOT #: UNKNOWN. (B)(4). EVENT DESCRIPTION CONTINUATION: THE FLOW SETTING WAS SET AT THE PRESET VALUE FOR THE SMART TOUCH SF. TOTAL ABLATION TIME AND LAST ABLATION TIME AT POSSIBLE SITE OF INJURY WERE THE SAME. ONE 10.4 SECOND BURN AT THE SITE OF INJURY. THEY DETERMINED THE POSSIBLE SITE OF INJURY BY IDENTIFYING THE ONLY BURN THAT HAD A SPIKE IN IMPEDANCE. THEY STOPPED THE ABLATION MANUALLY WITH REMOTE. THE VALUE CUT OFFS WERE NOT EXCEEDED. THEREFORE, THERE WERE NO ERRORS THAT POPULATED ON THE BIOSENSE WEBSTER, INC. SYSTEMS. THE PATIENT RECEIVED ANTICOAGULATION DURING THE PROCEDURE. THE ACTIVATED CLOTTING TIME (ACT) WAS MAINTAINED AT 250-300. THE SHAFT PROXIMITY INTERFERENCE (SPI) VALUE WAS UNKNOWN. THE SMART TOUCH BIDIRECTIONAL SF CATHETER WAS NOT CLOSE TO ANOTHER CATHETER. THE CATHETER WAS 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 CATHETER. SINCE THE 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.

    Additional Manufacturer Narrative · 1

    IN THE INITIAL 3500A REPORT, IT WAS REPORTED THAT THE TRANSSEPTAL NEEDLE WAS A DISTRIBUTED-HEARTSPAN/MODEL #: D-1348-05-S/LOT #: UNKNOWN. HOWEVER, THE CORRECT INFORMATION IS A NON BIOSENSE WEBSTER HEARTSPAN/CATALOG #: FND01901. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. THE PATIENT'S DIAGNOSIS PRE-PROCEDURE WAS PERSISTENT ATRIAL FIBRILLATION, CARDIOMYOPATHY, CHRONIC HEART FAILURE (CHF) AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). THE PATIENT WAS UNDER GENERAL ANESTHESIA. AFTER THE ABLATION, THE PATIENT WAS HYPOTENSIVE. AN ULTRASOUND WAS PERFORMED AND THE PERICARDIAL EFFUSION WAS CONFIRMED. A PERICARDIOCENTESIS WAS PERFORMED AND 400CC OF FLUID WAS REMOVED. HEPARIN WAS REVERSED. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED. THE PATIENT DID REQUIRE EXTENDED HOSPITALIZATION BY ONE ADDITIONAL DAY FOR OBSERVATION. A REPEAT ECHO SHOWED NO MORE PERICARDIAL EFFUSION AND WAS SENT HOME ON POST OPERATION DAY TWO. THE PATIENT FULLY RECOVERED. THE PHYSICIAN STATED THAT HE WAS WORRIED SOMETHING MAY HAPPEN BECAUSE OF THE PATIENT'S ENLARGED ATRIUM AND HISTORY OF LONG STANDING ATRIAL FIBRILLATION. THE PHYSICIAN'S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS THE PATIENT'S CONDITION AND PROCEDURE RELATED. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A HEARTSPAN TRANSSEPTAL NEEDLE. THE EVENT OCCURRED DURING THE ABLATION PHASE. THE GENERATOR WAS SET AT POWER CONTROL MODE. THE POWER WAS SET AT 25W AND BRIEFLY TURNED UP TO 26. THE TEMPERATURE CUT OFF VALUE WAS SET TO 40 C AND TEMPERATURE WARNING AT 37 C. THE BURN AT THE SUSPECTED SITE OF INJURY WAS FROM 27-30 C, IMPEDANCE WAS 140-156, AND THE POWER RANGED FROM 3-26 W. THE POWER WAS NOT TITRATED DURING ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735365 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S UNKNOWN_D-1348-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R