BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 7613860 · Received June 19, 2018

    Report

    Report Number
    2029046-2018-01695
    Event Type
    Death
    Date Received
    June 19, 2018
    Date of Event
    May 17, 2018
    Report Date
    May 22, 2018
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 6/19/2018, CONCOMITANT DEVICES WERE INADVERTENTLY OMITTED ON THE INITIAL MDR WHICH WAS SUBMITTED ON 6/19/2018 AS SUCH, THIS CORRECTION SUPPLEMENTAL IS BEING SUBMITTED WITH CONCOMITANT DETAILS. CONCOMITANT NON-BWI PRODUCTS: ST. JUDE MEDICAL ENSITE PRECISION CARDIAC MAPPING SYSTEM; ABBOTT MAPPING CATHETER; ABBOTT ABLATION CATHETERS X 3. (B)(4).

    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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED A PAPILLARY MUSCLE RUPTURE, VASCULAR DISSECTION, CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION AND DEFIBRILLATION), AND DEATH. LEFT VENTRICULAR ACCESS WAS GAINED VIA RETROGRADE AORTIC APPROACH. LEFT VENTRICULAR MAPPING WAS PERFORMED WITH THE ST. JUDE MEDICAL ENSITE PRECISION CARDIAC MAPPING SYSTEM AND AN ABBOTT MAPPING CATHETER. THE TARGET WAS A PVC ORIGINATING NEAR THE PAPILLARY MUSCLE. THE ABBOTT MAPPING CATHETER WAS REMOVED FROM THE BODY AND ABBOTT ABLATION CATHETER # 1 WAS CONNECTED AND INSERTED INTO THE PATIENT. PHYSICIAN WAS UNABLE TO PERFORM A RETROGRADE AORTIC APPROACH WITH ABBOTT ABLATION CATHETER # 1. ABBOTT ABLATION CATHETER # 1 WAS EXCHANGED FOR ABBOTT ABLATION CATHETER # 2, WHICH THE PHYSICIAN ALSO ATTEMPTED TO INSERT VIA A RETROGRADE AORTIC APPROACH WITHOUT SUCCESS. ABBOTT ABLATION CATHETER # 2 WAS EXCHANGED FOR ABBOTT ABLATION CATHETER # 3. SUBSEQUENTLY, THE PHYSICIAN REQUESTED A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND ATTEMPTED A RETROGRADE AORTIC APPROACH WITHOUT SUCCESS. PHYSICIAN RETURNED TO USING AN ABBOTT ABLATION CATHETER AND AFTER MULTIPLE ATTEMPTS WAS ABLE TO GAIN LEFT VENTRICULAR ACCESS. JUST PRIOR TO INITIATING ABLATION AT THE TARGET SITE, THE PATIENT¿S RHYTHM CHANGED TO WHAT APPEARED TO BE A 2:1 HEART BLOCK OR SIMILAR RHYTHM. ANESTHESIA PROVIDER EXPRESSED CONCERN REGARDING HEMODYNAMIC STABILITY AND EVALUATED THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) FOR A POSSIBLE EFFUSION. ICE REVEALED CARDIAC COMPRESSION, SO ECHOCARDIOGRAPHY WITH CONTRAST WAS PERFORMED. AT THAT POINT, THE RHYTHM DETERIORATED TO A STANDSTILL AND THEN VENTRICULAR FIBRILLATION. CPR AND DEFIBRILLATION WERE PERFORMED WITHOUT SUCCESS AND THE PATIENT EXPIRED. ECHOCARDIOGRAM WITH CONTRAST WAS REVIEWED AND AORTIC INSUFFICIENCY WAS OBSERVED, WHICH WAS DETERMINED TO LIKELY BE A CONTRIBUTING FACTOR IN THE DIFFICULTIES WITH THE CATHETERS CROSSING THE AORTIC VALVE. A LARGE DISSECTION WAS OBSERVED NEAR THE AORTIC ROOT, WHICH WAS BELIEVED TO BE CAUSED BY ONE OF THE ABLATION CATHETERS WHILE ATTEMPTING TO TRAVERSE THE AORTIC ARCH INTO THE LEFT VENTRICLE. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. IT IS UNKNOWN WHICH CATHETER WAS RESPONSIBLE FOR THE POSSIBLE EFFUSION AND DAMAGE TO THE AORTA. THERE WERE NO ISSUES, ERRORS, OR MALFUNCTIONS REPORTED ON ANY BWI PRODUCTS OR EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459637 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R