BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 19633325 · Received June 28, 2024

    Report

    Report Number
    2029046-2024-02144
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    April 12, 2024
    Report Date
    June 28, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835008982
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LV J, WANG R, YANG J, YOU L, YANG C, ZHANG Y, LIU Q, YIN L, LIU JT, XIE RQ. LEFT ATRIAL APPENDAGE CLOSURE IN CONJUNCTION WITH RADIOFREQUENCY ABLATION: EFFECTS ON LEFT ATRIAL FUNCTIONING IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION. OPEN MED (WARS). 2024 APR 12;19(1):20240951. DOI: 10.1515/MED-2024-0951. PMID: 38623457; PMCID: PMC11017190. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LV J, WANG R, YANG J, YOU L, YANG C, ZHANG Y, LIU Q, YIN L, LIU JT, XIE RQ. LEFT ATRIAL APPENDAGE CLOSURE IN CONJUNCTION WITH RADIOFREQUENCY ABLATION: EFFECTS ON LEFT ATRIAL FUNCTIONING IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION. OPEN MED (WARS). 2024 APR 12;19(1):20240951. DOI: 10.1515/MED-2024-0951. PMID: 38623457; PMCID: PMC11017190. OBJECTIVE/METHODS/STUDY DATA: OBJECTIVE IN THE PRESENT STUDY, WE INVESTIGATED THE IMPACT OF LEFT ATRIAL APPENDAGE CLOSURE (LAAC) FOLLOWING CATHETER ABLATION (CA) ON THE LEFT ATRIAL STRUCTURE AND FUNCTIONING OF PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION (AF). METHODS PATIENTS WITH PAROXYSMAL AF WERE ENROLLED IN THIS SINGLE-CENTER PROSPECTIVE COHORT STUDY BETWEEN APRIL 2015 AND JULY 2021; 353 PATIENTS RECEIVED CA ALONE, WHILE 93 PATIENTS RECEIVED CA IN COMBINATION WITH WATCHMAN LAAC. WE USED AGE, GENDER, CHA2DS2-VASC, AND HAS-BLED SCORES AS WELL AS OTHER DEMOGRAPHIC VARIABLES TO PERFORM PROPENSITY SCORE MATCHING. PATIENTS WITH PAROXYSMAL AF WERE RANDOMLY ASSIGNED TO THE CA COMBINED WITH WATCHMAN LAAC GROUP (COMBINED TREATMENT GROUP) AND THE SIMPLE CA GROUP, WITH 89 PATIENTS IN EACH GROUP. THE LEFT ATRIAL STRUCTURE, RESERVE, VENTRICULAR DIASTOLE, AND PUMP FUNCTIONS AND THEIR CHANGES IN PATIENTS WERE ASSESSED USING ROUTINE DOPPLER ECHOCARDIOGRAPHY AND 2D SPECKLE TRACKING ECHOCARDIOGRAPHY OVER THE COURSE OF A 1-YEAR FOLLOW-UP. RESULTS AT 1-WEEK FOLLOW-UP, THE RESERVE, VENTRICULAR DIASTOLE, AND PUMP FUNCTIONS OF THE LEFT ATRIUM (LA) INCREASED IN BOTH GROUPS; THESE FUNCTIONS WERE GRADUALLY RESTORED AT THE 1- TO 3-MONTH FOLLOW-UP; THEY WERE CLOSE TO OR RETURNED TO THEIR PRE-OPERATIVE LEVELS AT THE 3-MONTH FOLLOW-UP; AND NO SIGNIFICANT DIFFERENCES WERE FOUND COMPARED WITH THE PREOPERATIVE LEVELS AT THE 12-MONTH FOLLOW-UP. IN THE FIRST 3 MONTHS, THE RESERVE (, SRS) AND PUMP FUNCTIONS (SRA) IN THE COMBINED TREATMENT GROUP DECREASED SIGNIFICANTLY WHEN COMPARED WITH THE SIMPLE CA GROUP, AND THE DIFFERENCES WERE STATISTICALLY SIGNIFICANT. CONCLUSION PATIENTS WITH PAROXYSMAL AF MAY EXPERIENCE A SHORT TERM, PARTIAL EFFECT OF LAAC ON LA RESERVE AND PUMP FUNCTIONS, WHICH ARE GRADUALLY RESTORED AND THE EFFECT DISAPPEARS BY 12 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH. CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO, LASSO CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: WATCHMAN BOSTON SCIENTIFIC. OF NOTE, THERE WERE SOME ADVERSE EVENTS THAT OCCURRED OVER 2 MONTHS POST PROCEDURE THAT ARE NOT BEING ASSOCIATED WITH THE CATHETER OR PROCEDURE. IN ADDITION, VASCULAR COMPLICATIONS WERE REPORTED THAT ARE ASSOCIATED WITH THE SHEATH USED FOR VASCULAR ACCESS, HOWEVER, THE IDENTITY OF THE SHEATH WAS NOT PROVIDED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH: QTY 4 ¿ PERICARDIAL EFFUSION DURING SURGERY BUT RECOVERED NORMALLY AFTER PERCUTANEOUS DRAINAGE (CARDIAC TAMPONADE)(RECOGNIZED PROCEDURAL COMPLICATIONS); QTY 1 ¿ PATIENT DEVELOPED A SMALL AMOUNT OF HEMOPTYSIS DURING SURGERY (HEMOPTYSIS)(MAJOR INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827887 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835008982

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L CARTO.| LASSO.| WATCHMAN BOSTON SCIENTIFIC.