BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFFG-24

    MDR report key: 10171460 · Received June 18, 2020

    Report

    Report Number
    3008782989-2020-00001
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    May 16, 2020
    Report Date
    June 18, 2020
    Manufacturer
    CLEARFLOW, INC.
    Product Code
    OTK
    UDI-DI
    20856449006066
    PMA / PMN Number
    163139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BETWEEN 2% AND 8% OF ALL PATIENTS HAVE TO GO BACK FOR POST OP FOR BLEEDING AFTER CARDIAC SURGERY. (THIS IS QUOTED IN THE LOOR PAPER WITH REFERENCES). SIDE BRANCH BLEEDING IS ONE OF THE MOST COMMON SOURCES OF BLEEDING WHEN A PATIENT IS TAKEN BACK. CLEARFLOW DEVICE IS INTENDED TO REMOVE CLOTS FORMED INSIDE THE CHEST TUBE.

    Description of Event or Problem · 1

    A DAY AFTER CABGX2 PROCEDURE, THE PATIENT WAS TAKEN BACK TO REPAIR A TORN VEIN GRAFT. THE CUSTOMER REPORTED THAT A CLIP ON THE PATIENT'S GRAFT MAY HAVE BEEN ATTACHED TO THE BLOOD CLOT REMOVED. THE PFFG WAS PLACED IN ANTERIOR MEDIASTINUM. THERE IS NO INFORMATION AVAILABLE IF THERE WAS A CLIP USED AT THE SITE, ACCORDING TO THE CUSTOMER.. NO CLIP WAS FOUND IN THE CF DEVICE OR DRAINAGE CANISTER ACCORDING TO THE HOSPITAL. THERE WAS NO SERIOUS INJURY. THE PATIENT'S GRAFT WAS SUTURED AND ANOTHER PFFG WAS USED . THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635164 PFFG-24 CATHETER OTK CLEARFLOW, INC. PFFG-24 1011105 20856449006066

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other