BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL

    MDR report key: 14688535 · Received June 14, 2022

    Report

    Report Number
    2029046-2022-01297
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    October 13, 2021
    Report Date
    June 14, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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: ANDRÉS LAHUERTA A, ROBERTO C, SAIZ FJ, CANO Ó, MARTÍNEZ-MATEU L, ALONSO P, SAURÍ A, QUESADA A, OSCA J. ATRIAL LOW VOLTAGE AREAS: A COMPARISON BETWEEN ATRIAL FIBRILLATION AND SINUS RHYTHM. CARDIOL J. 2022;29(2):252-262. DOI: 10.5603/CJ.A2021.0125. EPUB 2021 OCT 13. PMID: 34642920; PMCID: PMC9007488. THE LITERATURE FILE IS TOO LARGE TO ATTACH. 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 THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER¿S REFERENCE NUMBER: PC-(B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ANDRÉS LAHUERTA A, ROBERTO C, SAIZ FJ, CANO Ó, MARTÍNEZ-MATEU L, ALONSO P, SAURÍ A, QUESADA A, OSCA J. ATRIAL LOW VOLTAGE AREAS: A COMPARISON BETWEEN ATRIAL FIBRILLATION AND SINUS RHYTHM. CARDIOL J. 2022;29(2):252-262. DOI: 10.5603/CJ.A2021.0125. EPUB 2021 OCT 13. PMID: 34642920; PMCID: PMC9007488. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: ATRIAL FIBROSIS CAN PROMOTE ATRIAL FIBRILLATION (AF). ELECTROANATOMIC MAPPING (EAM) CAN PROVIDE INFORMATION REGARDING LOCAL VOLTAGE ABNORMALITIES THAT MAY BE USED AS A SURROGATE MARKER FOR FIBROSIS. SPECIFIC VOLTAGE CUT-OFF VALUES HAVE BEEN REPRODUCED ACCURATELY TO IDENTIFY FIBROSIS IN THE VENTRICLES, BUT THESE VALUES ARE NOT WELL DEFINED IN ATRIAL TISSUE. METHODS: THIS STUDY IS A PROSPECTIVE SINGLE-CENTER STUDY. PATIENTS WITH PERSISTENT AF REFERRED FOR ABLATION WERE INCLUDED. EAM WAS PERFORMED BEFORE ABLATION. WE RECORDED BIPOLAR SIGNALS, FIRST IN AF AND LATER IN SINUS RHYTHM (SR). TWO THRESHOLDS DELIMITED LOW-VOLTAGE AREAS (LVA), 0.5 AND 0.3 MV. WE COMPARED LVA EXTENSION BETWEEN MAPS IN SR AND AF IN EACH PATIENT. RESULTS: A TOTAL OF 23 PATIENTS WERE INCLUDED IN THE STUDY. THE PERCENTAGE OF POINTS WITH VOLTAGE LOWER THAN 0.5 MV AND 0.3 MV WAS SIGNIFICANTLY HIGHER IN MAPS IN AF COMPARED WITH MAPS IN SR: 38.2% OF POINTS < 0.5 MV IN AF VS. 22.9% IN SR (P < 0.001); 22.3% OF POINTS < 0.3 MV IN AF VS. 14% IN SR (P < 0.001). AREAS WITH REDUCED VOLTAGE WERE SIGNIFICANTLY LARGER IN MAPS IN AF (0.5 MV THRESHOLD, MEAN AREA IN AF 41.3 ± 42.5 CM2 VS. 11.7 ± 17.9 CM2 IN SR, P < 0.001; 0.3 MV THRESHOLD, MEAN AREA IN AF 15.6 ± 22.1 CM2 VS. 6.2 ± 11.5 CM2 IN SR, P < 0.001). CONCLUSIONS: USING THE SAME VOLTAGE THRESHOLDS, LVA EXTENSION IN AF IS GREATER THAN IN SR IN PATIENTS WITH PERSISTENT AF. THESE FINDINGS PROVIDE ARGUMENTS FOR DEFINING A DIFFERENT ATRIAL FIBROSIS THRESHOLD BASED ON EAM RHYTHM. (CARDIOL J 2022; 29, 2: 252¿262) LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMARTTOUCH SF. OTHER BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: PENTARAY. DECAPOLAR CATHETER WEBSTER. CS CATHETER. NON-BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: 1 SL0 SHEATH. 1 AGILIS SHEATH; ST. JUDE MEDICAL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: (1) CASE OF CARDIAC TAMPONADE WHICH WAS SOLVED BY PERICARDIOCENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489803 UNK_SMART TOUCH BIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R AGILIS SHEATH| CS CATHETER| DECAPOLAR CATHETER WEBSTER| PENTARAY| SL0 SHEATH