BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 12825226 · Received November 16, 2021

    Report

    Report Number
    2029046-2021-01990
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    October 9, 2021
    Report Date
    November 16, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF # PC-001011316. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TONEGAWA-KUJI R, YAMAGATA K, SUZUKI S, MIYAZAKI Y, UEDA N, KUSANO K. PROMPT RECOGNITION AND SUCCESSFUL ASPIRATION OF A LEFT ATRIAL THROMBUS UNDER INTRACARDIAC ECHOCARDIOGRAPHY GUIDANCE DURING RADIOFREQUENCY CATHETER ABLATION FOR ATRIAL TACHYCARDIA. EUROPACE. (B)(6) 2021; 23(10):1527. DOI: 10.1093/EUROPACE/EUA(B)(4). PMID: (B)(4). SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TONEGAWA-KUJI R, YAMAGATA K, SUZUKI S, MIYAZAKI Y, UEDA N, KUSANO K. PROMPT RECOGNITION AND SUCCESSFUL ASPIRATION OF A LEFT ATRIAL THROMBUS UNDER INTRACARDIAC ECHOCARDIOGRAPHY GUIDANCE DURING RADIOFREQUENCY CATHETER ABLATION FOR ATRIAL TACHYCARDIA. EUROPACE. (B)(6) 2021; 23(10):1527. DOI: 10.1093/EUROPACE/(B)(4) PMID: (B)(4). OBJECTIVE/METHODS/STUDY DATA: A CASE REPORT OF AN (B)(6) WOMAN WITH PERSISTENT ATRIAL TACHYCARDIA WHO UNDERWENT CATHETER ABLATION, DURING WHICH CONTINUOUS INTRACARDIAC ECHOCARDIOGRAPHY (ICE)-BASED MONITORING OF THE ABLATION SITE REVEALED AN RFA-RELATED THROMBUS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SURROUND FLOW CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ICE CARTO NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: AGILIS SHEATH (ABBOT). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: DURING LINEAR ABLATION ACROSS THE LA PW (30W; CONTACT FORCE, 10¿20 G; AND ABLATION INDEX, 350), ICE (CARTO SOUNDVR) DETECTED A MOBILE THROMBUS AT THE PW¿S CENTRE. THE THROMBUS WAS SUCCESSFULLY ASPIRATED UNDER ICE GUIDANCE. ICE CONFIRMED COMPLETE THROMBUS REMOVAL. AT FOLLOW-UP, NO TRANSIENT ISCHAEMIC ATTACK OR STROKE WAS NOTED; THE HYPERCOAGULABLE WORKUP WAS UNREMARKABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717214 UNK_SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Life Threatening| R AGILIS SHEATH (ABBOT).