BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXSEAL¿ INTRODUCER SHEATH WITH HYDROPHILIC COATING

    MDR report key: 16734638 · Received April 13, 2023

    Report

    Report Number
    1000121130-2023-00001
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    October 31, 2022
    Report Date
    April 13, 2023
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    DYB
    UDI-DI
    00802526618000
    PMA / PMN Number
    K190628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT SEEN TO BE IN BBB AS NOTED IN LAB. TWO SEEN IN EACH VECTOR (BOTH PACED AND NON PACED MORPHOLOGIES), AUTO SETUP COMPLETED WITH FAILURE IN ALL VECTORS. SMART PASS ORIGINALLY SEEN TO TURN OFF DUE TO OVERSENSING IN SECONDARY VECTOR. PROGRAMMED PRIMARY X2 GAIN WITH SMART PASS ON AS PER BOSTON SCIENTIFIC, DR. (B)(6) CONSULTED. FOR 1/52 DL TO REVIEW RHYTHM ON INTERROGATION SAME BBB MORPHOLOGY BUNDLE BRANCH BLOCK THAT DEVELOPED DURING IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026650 FLEXSEAL¿ INTRODUCER SHEATH WITH HYDROPHILIC COATING INTRODUCER SHEATH DYB FREUDENBERG MEDICAL, LLC 8782 PD06 00802526618000

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other BOSTON SCIENTIFIC DELIVERY CATHETER| BOSTON SCIENTIFIC LEADLESS CARDIAC PACEMAKER