BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRUITT-INAHARA CAROTID SHUNT

    MDR report key: 254836 · Received December 16, 1999

    Report

    Report Number
    1056436-1999-00214
    Event Type
    Other
    Date Received
    December 16, 1999
    Report Date
    November 19, 1999
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    DQR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 11/19/1999, THE DISTRIBUTOR INFORMED THE MFR THAT A CUSTOMER IN THEIR TERRITORY EXPERIENCED A PROBLEM WITH A PRODUCT. THE FACILITY, CATALOG/LOT NUMBER, PT/PHYSICIAN, EVENT DATE, ETC WAS NOT KNOWN AT THE TIME OF THE CONTACT. ON 11/19/1999, THE MFR FAXED A BLANK PCR REPORT TO THE DISTRIBUTOR FOR COMPLETION. ON 12/09/1999, THE MFR RECEIVED THE COMPLETED PCR FORM THAT STATES THE FOLLOWING: THE PHYSICIAN OPENED BOTH DEVICES FOR THE PROCEDURE; PHYSICIAN CLAIMED BOTH BALLOONS LEAKING. THE DEVICES ARE SCHEDULED TO BE RETURNED TO THE MFR FOR ANALYSIS; HOWEVER, THE DEVICES HAVE NOT BEEN RETURNED TO DATE. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. SUBMITTED TO THE FDA 12/16/1999.

    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 I012099-03/IO12699-08

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other