BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESHEATH II

    MDR report key: 19713876 · Received July 9, 2024

    Report

    Report Number
    MW5157150
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 5, 2024
    Manufacturer
    PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN THE EP(ELECTROPHYSIOLOGY) LAB, USED A SAFESHEATH II BY PRESSURE PRODUCTS. AS PHYSICIAN PEELED AWAY THE SHEATH FROM THE LEAD, THE DISC DID NOT SPLIT IN HALF. SAFESHEATH AND DISC REMOVED INTACT FROM PATIENT WITHOUT HARM TO PATIENT OR ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348208 SAFESHEATH II INTRODUCER, CATHETER DYB PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC SS6 DP20958

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male