BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 19757094 · Received July 16, 2024

    Report

    Report Number
    2029046-2024-02378
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    March 24, 2024
    Report Date
    July 16, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: YANO M, EGAMI Y, KAWANAMI S, UKITA K, KAWAMURA A, YASUMOTO K, TSUDA M, OKAMOTO N, MATSUNAGA-LEE Y, NISHINO M. COMPARISON OF POSTPROCEDURAL P-WAVE VECTOR MAGNITUDE ON 12-LEAD ELECTROCARDIOGRAM BETWEEN CRYOBALLOON AND RADIOFREQUENCY ABLATION. AM J CARDIOL. 2024 JUN 1;220:1-8. DOI: 10.1016/J.AMJCARD.2024.03.018. EPUB 2024 MAR 24. PMID: 38522652. 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: YANO M, EGAMI Y, KAWANAMI S, UKITA K, KAWAMURA A, YASUMOTO K, TSUDA M, OKAMOTO N, MATSUNAGA-LEE Y, NISHINO M. COMPARISON OF POSTPROCEDURAL P-WAVE VECTOR MAGNITUDE ON 12-LEAD ELECTROCARDIOGRAM BETWEEN CRYOBALLOON AND RADIOFREQUENCY ABLATION. AM J CARDIOL. 2024 JUN 1;220:1-8. DOI: 10.1016/J.AMJCARD.2024.03.018. EPUB 2024 MAR 24. PMID: 38522652. OBJECTIVE/METHODS/STUDY DATA: PULMONARY VEIN ISOLATION (PVI) CAUSES CHANGES IN P-WAVE PARAMETERS. HOWEVER, THE DIFFERENCE IN CHANGES IN P-WAVE PARAMETERS INCLUDING P-WAVE VECTOR MAGNITUDE (PVM) BETWEEN RADIOFREQUENCY CATHETER ABLATION (RFCA) AND CRYOBALLOON ABLATION (CBA) REMAINS UNKNOWN. PAROXYSMAL ATRIAL FIBRILLATION (PAF) PATIENTS WHO UNDERWENT ONLY PVI WERE ENROLLED. PVM WAS CALCULATED BY THE SQUARE ROOT OF THE SUM OF THE SQUARED P-WAVE AMPLITUDE IN LEADS II AND V6 AND ONE-HALF OF THE P-WAVE AMPLITUDE IN V2. THE PATIENTS WERE DIVIDED INTO 2 GROUPS: RFCA AND CBA. DPVM WAS CALCULATED AS DPVM (MV) = (PVM AT PRE-PVI)-(PVM AT POST-PVI). THE FOLLOWING FACTORS WERE EVALUATED: (1) DIFFERENCES IN THE DPVM BETWEEN THE 2 GROUPS, (2) RELATION BETWEEN LATE ARRHYTHMIA RECURRENCE AND DPVM IN RFCA AND CBA GROUPS, AND (3) THE IMPACT OF RELEVANT FACTORS ON DPVM. THE STUDY POPULATION INCLUDED A TOTAL OF 426 PATIENTS WITH PAF (RFCA, 167 PATIENTS; CBA, 259 PATIENTS). DPVM WAS SIGNIFICANTLY LARGER IN CBA THAN IN RFCA. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH CATHETER. CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: 8.5 FR SL0 (ABBOTT LABORATORIES), A STEERABLE SHEATH FLEXCATH (MEDTRONIC, MINNEAPOLIS, MINNESOTA), ACHIEVE CRYOABLATION CATHETER (MEDTRONIC). THE PSEUDOANEURYSMS REPORTED IN THE RF ABLATION GROUP IS NOT RELATED TO THE ABLATION CATHETER AND INSTEAD RELATED TO THE SHEATH USED FOR VASCULAR ACCESS, HOWEVER, THE SHEATH IN THE RF ABLATION GROUP WAS NOT IDENTIFIED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH CATHETER: QTY 1 ¿ (CARDIAC TAMPONADE)(RECOGNIZED PROCEDURAL COMPLICATION) QTY 1 ¿ PHRENIC NERVE PALSY (DIAPHRAGMATIC PARALYSIS)(RECOGNIZED PROCEDURAL COMPLICATION). QTY 2 ¿ (GASTROPARESIS)(SERIOUS INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507498 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening