BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL

    MDR report key: 9955798 · Received April 13, 2020

    Report

    Report Number
    2029046-2020-00544
    Event Type
    Injury
    Date Received
    April 13, 2020
    Date of Event
    December 31, 2018
    Report Date
    March 25, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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, ¿ULTRA¿HIGH DENSITY MAPPING OF CONDUCTION GAPS AND ATRIAL TACHYCARDIAS: DISTINCTIVE PATTERNS FOLLOWING PULMONARY VEIN ISOLATION WITH CRYOBALLOON OR CONTACT¿FORCE-GUIDED RADIOFREQUENCY CURRENT¿. A PATIENT WITH RECURRENCE OF ATRIAL FIBRILLATION WHO UNDERWENT RADIOFREQUENCY CURRENT (RFC) PULMONARY VEIN ISOLATION (PVI) EXPERIENCED PERICARDIAL TAMPONADE IN THE CF-RFC GROUP, THE PATIENT REQUIRED IMMEDIATE PERICARDIOCENTESIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, 3 DAYS LATER, IN GOOD MEDICAL CONDITION. THE AIM OF THIS STUDY WAS TO INVESTIGATE ELECTROPHYSIOLOGICAL FINDINGS IN PATIENTS WITH ARRHYTHMIA RECURRENCE UNDERGOING A REPEAT ABLATION PROCEDURE USING ULTRA¿HIGH-DENSITY (UHDX) MAPPING FOLLOWING AN INDEX PROCEDURE USING EITHER CONTACT¿FORCE (CF)-GUIDED RADIOFREQUENCY CURRENT (RFC) PULMONARY VEIN ISOLATION (PVI) OR SECOND-GENERATION CRYOBALLOON (CB) PVI FOR TREATMENT OF ATRIAL FIBRILLATION (AF). METHODS: BETWEEN NOVEMBER 2017 AND DECEMBER 2018, FIFTY CONSECUTIVE PATIENTS WITH RECURRENCE OF AF AND/OR ATRIAL TACHYCARDIA (AT) FOLLOWING INDEX CF-RFC PVI (N = 21) OR CB PVI (N = 29) WERE INCLUDED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419113 UNK_SMART TOUCH BIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention