BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLASSIC SHEATH 6FCLS-1006

    MDR report key: 5399641 · Received January 29, 2016

    Report

    Report Number
    2017865-2016-00574
    Event Type
    Injury
    Date Received
    January 29, 2016
    Date of Event
    January 5, 2016
    Report Date
    January 5, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    OEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PNEUMOTHORAX OCCURRED DURING THE IMPLANT PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS ASSOCIATED WITH PNEUMOTHORAX. A CHEST TUBE WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57944 CLASSIC SHEATH 6FCLS-1006 CADRIOVASCULAR CATHETER SHEATH INTRODUCER KIT OEX ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CLS-1006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention