BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE PRODUCTS 6FR. SAFE SHEATH

    MDR report key: 11131712 · Received January 6, 2021

    Report

    Report Number
    MW5098715
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    January 2, 2021
    Report Date
    January 4, 2021
    Manufacturer
    PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING DUAL CHAMBER PACEMAKER INSERTION IN EP LAB, INTRODUCER SHEATH USED TO INTRODUCE PACEMAKER LEAD WAS DEFECTIVE. DILATOR SHAFT BECAME DETACHED FROM DILATOR CAP WHEN ATTEMPTING TO REMOVE DILATOR AND J WIRE USED TO OBTAIN SUBCLAVIAN VEIN ACCESS FOR PACEMAKER LEAD INSERTION. SHAFT OF DILATOR AND J WIRE WERE ABLE TO BE REMOVED WITHOUT INCIDENT. SUPPLY CHAIN MANAGEMENT NOTIFIED AND PLAN TO CONTACT MANUFACTURER OF PRODUCT. PRODUCT MADE BY 'PRESSURE PRODUCTS' 6FR SAFESHEATHII, REFERENCE NUMBER SS6, LOT NUMBER: DP12097, FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19303 PRESSURE PRODUCTS 6FR. SAFE SHEATH INTRODUCER, CATHETER DYB PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC 6FR SAFE SHEATH 12099 DP12097

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other