BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRUITT-INAHARA CAROTID SHUNT

    MDR report key: 280289 · Received May 31, 2000

    Report

    Report Number
    1056436-2000-00101
    Event Type
    Malfunction
    Date Received
    May 31, 2000
    Date of Event
    April 25, 2000
    Report Date
    April 26, 2000
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    DQR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 05/02/2000, THE MFR RECEIVED A MEDWATCH REPORT (UF# NOT INCLUDED) THAT STATES THE FOLLOWING: BALLOON BURST WHILE IN PT'S CAROTID ARTERY. OUTCOME UNKNOWN AT THIS TIME. THE CATALOG NUMBER ON THE FACILITY'S MEDWATCH REPORT WAS INCORRECT AND A LOT NUMBER WAS NOT PROVIDED. AS A RESULT, ON 05/02/2000, THE MFR CONTACTED THE FACILITY'S RISK MANAGER TO OBTAIN THE CORRECT INFO. ON 05/26/2000, THE FACILITY'S RISK MANAGER INFORMED THE MFR'S REPRESENTATIVE THAT THE CORRECT CATALOG NUMBER OF THE DEVICE IN QUESTION IS 400-40-9F, LOT NUMBER I051499-19. ADDITIONALLY, RISK MANAGER STATED THAT THE PRODUCT WOULD NOT BE RETURNED TO THE MFR FOR ANALYSIS. THE FACILITY'S RISK MANAGER WAS INFORMED THAT SINCE THE PRODUCT WOULD NOT BE RETURNED TO THE MFR FOR ANALYSIS, THE MFR'S INVESTIGATION OF THIS EVENT WOULD BE LIMITED TO A TREND ANALYSIS, A REVIEW OF THE DEVICE HISTORY RECORD AND TESTING OF RETAIN SAMPLES. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRUITT-INAHARA CAROTID SHUNT CATHETER, CANNULA AND TUBING, VASCULAR SHUNT DQR HORIZON MEDICAL PRODUCTS, INC. NA I051499-19

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other