BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 10089319 · Received May 26, 2020

    Report

    Report Number
    2029046-2020-00619
    Event Type
    Injury
    Date Received
    May 26, 2020
    Date of Event
    December 31, 2018
    Report Date
    May 4, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿HIGH-POWER APPLICATION IS ASSOCIATED WITH SHORTER PROCEDURE TIME AND HIGHER RATE OF FIRST-PASS PULMONARY VEIN ISOLATION IN ABLATION INDEX-GUIDED ATRIAL FIBRILLATION ABLATION¿ 1 PATIENT WITH ATRIAL FIBRILLATION, FROM LP-GROUP, WHO UNDERWENT CIRCUMFERENTIAL PULMONARY VEIN ISOLATION EXPERIENCED ARTERIOVENOUS FISTULA IN THE FEMORAL VEIN PUNCTURE SITE. OBJECTIVES: ABLATION INDEX PF THE CIRCUMFERENTIAL PULMONARY VEIN ISOLATION (CPVI) AND THE ROLE OF RADIOFREQUENCY POWER IN AI-GUIDED CPVI WERE REVIEWED. METHODS: 60 PATIENTS WITH AF UNDERGOING THE FIRST CPVI FROM JULY 2018 TO DECEMBER 2018 WERE INVESTIGATED. NO PATIENTS WITH LONG-STANDING AF WERE INCLUDED IN THIS STUDY. IN THE FIRST PART OF THE STUDY, WE RANDOMLY ASSIGNED THE 40 PATIENTS TO LP (N = 20) AND MEDIUM-POWER (MP; N = 20) APPLICATION GROUPS (FIGURE 1). IN THE NEXT PART, THE FOLLOWING 20 PATIENTS TO THE HP APPLICATION GROUP WERE ASSIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552261 UNK_SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other