BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE PRODUCTS

    MDR report key: 4847382 · Received June 9, 2015

    Report

    Report Number
    MW5043065
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 29, 2015
    Manufacturer
    PRESSURE PRODUCTS MEDICAL SUPPLIES, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SAFESHEATH USED FOR ACCESS DURING A PACEMAKER IMPLANT WAS FOUND TO HAVE A BREAK IN THE SEAL. AS A RESULT, THERE IS A RISK FOR INTRAVASCULAR AIR, HAD THIS DEVICE BEEN LEFT IN PLACE. THE PHYSICIAN NOTED THE PROBLEM AND REPLACED THE SHEATH WITH A DIFFERENT BRAND SHEATH. THE VEIN ACCESSED WAS NORMAL WITHOUT EVIDENCE OF DISEASE. THE 7FR X 13 CM SAFESHEATH II. THE 0.035 X 50 CM J WIRE. NOTHING ELSE WAS INTRODUCED TO THE SHEATH. THE SHEATH IS SPLITTING ALONG THE SEAM OR POSSIBLY THE DIAPHRAGM CAUSING AIR TO ENTER THE SHEATH AND POTENTIALLY THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369706 PRESSURE PRODUCTS SAFESHEATH II DYB PRESSURE PRODUCTS MEDICAL SUPPLIES, INC. SS7 DB-03113

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR