BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH UNIDIRECTIONAL SF

    MDR report key: 12840668 · Received November 18, 2021

    Report

    Report Number
    2029046-2021-01997
    Event Type
    Injury
    Date Received
    November 18, 2021
    Date of Event
    September 20, 2021
    Report Date
    November 18, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE CANNOT BE ATTACHED AS THE ELECTRONIC FILE SIZE IS TOO LARGE. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MULDER MJ, KEMME MJB, HOPMAN LHGA, KUSGÖZOGLU E, GÜLÇIÇEK H, VAN DE VEN PM, HAUER HA, TAHAPARY GJM, GÖTTE MJW, VAN ROSSUM AC, ALLAART CP. COMPARISON OF THE PREDICTIVE VALUE OF TEN RISK SCORES FOR OUTCOMES OF ATRIAL FIBRILLATION PATIENTS UNDERGOING RADIOFREQUENCY PULMONARY VEIN ISOLATION. INT J CARDIOL. (B)(6) 2021: (B)(4). DOI: 10.1016/J.IJCARD.2021.09.029. EPUB AHEAD OF PRINT. PMID: (B)(4). 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. 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: MULDER MJ, KEMME MJB, HOPMAN LHGA, KUSGÖZOGLU E, GÜLÇIÇEK H, VAN DE VEN PM, HAUER HA, TAHAPARY GJM, GÖTTE MJW, VAN ROSSUM AC, ALLAART CP. COMPARISON OF THE PREDICTIVE VALUE OF TEN RISK SCORES FOR OUTCOMES OF ATRIAL FIBRILLATION PATIENTS UNDERGOING RADIOFREQUENCY PULMONARY VEIN ISOLATION. INT J CARDIOL. (B)(6) 2021: (B)(4). DOI: 10.1016/J.IJCARD.2021.09.029. EPUB AHEAD OF PRINT. PMID: (B)(4) . OBJECTIVE/METHODS/STUDY DATA: TO COMPARE TEN PREVIOUSLY DESCRIBED RISK SCORES WITH REGARD TO THEIR PREDICTIVE VALUE FOR POST-ABLATION AF RECURRENCE AND PROCEDURAL COMPLICATIONS. A TOTAL OF 482 AF PATIENTS ((B)(6) PAROXYSMAL AF, (B)(6) MALE, MEAN AGE (B)(6)) UNDERGOING INITIAL RADIOFREQUENCY PULMONARY VEIN ISOLATION (PVI) WERE INCLUDED IN THE PRESENT ANALYSIS. PRIOR TO ABLATION, ALL PATIENTS UNDERWENT BOTH TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) AND EITHER CARDIAC CT IMAGING OR CMR IMAGING. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: CONTACT FORCE-SENSING ABLATION CATHETER (SMARTTOUCH) OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: LASSO CATHETER, CARTO 3, VISITAG NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ITKJ SNAP SOFTWARE, MESHLAB SOFTWARE, MATLAB SOFTWARE ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: (QTY 1) PERICARDIAL EFFUSION NOT REQUIRING DRAINAGE (QTY 2) CVA/TIA (QTY 1) PERICARDIAL EFFUSION/TAMPONADE REQUIRING DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737362 SMART TOUCH UNIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R