BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEERABLE INTRODUCER SHEATH 12F

    MDR report key: 11796590 · Received May 10, 2021

    Report

    Report Number
    1000121130-2021-00001
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 6, 2021
    Report Date
    May 4, 2021
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    DRA
    UDI-DI
    00850004312049
    PMA / PMN Number
    K192422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SHEATH DURING A PATIENT PROCEDURE THE BALLOON RUPTURED IN THE HEART. THE PATIENT'S CHEST HAD TO BE OPENED SO THE THAT THE DEVICE COULD BE MANUALLY REMOVED. THE PATIENT IS REPORTEDLY STABLE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693564 STEERABLE INTRODUCER SHEATH 12F STEERABLE INTRODUCER SHEATH DRA FREUDENBERG MEDICAL, LLC SS120065 UNKNOWN 00850004312049

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention