BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRUITT F3

    MDR report key: 2160552 · Received July 6, 2011

    Report

    Report Number
    2160552
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    NIM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DESCRIPTION OF FINDINGS: 1) HIGH-GRADE STENOSIS, 95% PLUS, PROXIMAL RIGHT INTERNAL CAROTID ARTERY. 2) INTRAOPERATIVE COMPLICATION OF 4 MM LINEAR TEAR SECONDARY TO DEFECTIVE BALLOON DEFLATION OF SHUNT, APPROXIMATELY 3 CM SUPERIOR TO RIGHT INTERNAL CAROTID ARTERY TAKEOFF - REPAIR PRIMARILY.ESTIMATED BLOOD LOSS: 2500 CC.COMPLICATIONS: A 4 MM LINEAR TEAR MID RIGHT INTERNAL CAROTID ARTERY 3 CM SUPERIOR TO BIFURCATION PRIMARILY REPAIRED WITH (DICTATION ANOMALY) 1400 CC BLOOD LOSS, FELT SECONDARY TO INADEQUATE BALLOONDESUFFLATION UPON SHUNT REMOVAL.======================MANUFACTURER RESPONSE FOR CAROTID SHUNT, PRUITT F3 (PER SITE REPORTER)======================MANUFACTURER REPRESENTATIVE CAME AND REMOVED ALL REMAINING SHUNTS FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRUITT F3 CAROTID SHUNT NIM LEMAITRE VASCULAR 2012-10 PFT2125

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention