BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3

    MDR report key: 2240893 · Received August 29, 2011

    Report

    Report Number
    2240893
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    CORDIS
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO OPEN A CLOTTED ARTERIOVENOUS (AV) FISTULA. HE REQUESTED THE 0.035 GLIDE WIRE AND ATTEMTPED TO ADVANCE IT THROUGH THE CATHETER, BUT WAS UNBLE TO DO SO. THERE WERE NO OBVIOUS DEFECTS TO THE EQUIPMENT. THE SURGICAL TEAM IS VERY EXPERIENCED IN USING THIS EQUIPMENT AND DID NOT ANTICIPATE THIS HAPPENING. THE SURGEON REQUESTED ANOTHER GLIDE WIRE, WHICH WAS FROM THE SAME LOT, AND WAS ABLE TO ADVANCE IT THROUGH THE CATHETER WITHOUT DIFFICULTY. THERE WAS NO HARM TO THE PATIENT. THE SURGICAL PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.======================MANUFACTURER RESPONSE FOR PTA DILATION CATHETER, CORDIS POWERFLEX P3 (PER SITE REPORTER)======================CLINICAL INVENTORY NOTIFIED THE MANUFACTURER VIA TELEPHONE. (B)(4). WHEN BUSINESS REOPENS, CLINICAL INVENTORY WILL CONTACT THEM AGAIN AND SEND OUT THE PRODUCT/PACKAGING FOR THEIR INSPECTION & ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT CORDIS * 15339522

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR