BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 1677121 · Received May 7, 2010

    Report

    Report Number
    1056128-2010-00011
    Event Type
    Injury
    Date Received
    May 7, 2010
    Date of Event
    April 9, 2010
    Report Date
    July 15, 2010
    Manufacturer
    ASCENT HALTHCARE SOLUTIONS
    Product Code
    NMF
    PMA / PMN Number
    K011832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THE DEVICE INVESTIGATION HAD NOT BEEN COMPLETED. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS IS THE FIRST COMPLAINT ASCENT HAS RECEIVED FOR A FEMOSTOP CAUSING A PSEUDO ANEURYSM.

    Additional Manufacturer Narrative · 1

    THIS MDR IS ASSOCIATED WITH AN ASCENT VOLUNTARY RECALL FOR SIX (6) FEMOSTOP LOT NUMBERS WHERE THE DEVICE MAY FAIL TO INFLATE PROPERLY AND MAY LEAK DUE TO A SEAL SEPARATION BETWEEN THE DOME AND PLASTIC ARCH BASE. ON JUNE 18TH ASCENT INITIATED A VOLUNTARY RECALL FOR THE SIX FEMOSTOP LOT NUMBERS SO THIS FOLLOW-UP MDR IS BEING FILED DUE TO THE ADDITIONAL INFORMATION OBTAINED DURING THE RECALL. THE PATIENT INFORMATION WAS NOT PROVIDED TO ASCENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FEMOSTOP SEAL WAS LEAKING AND CAUSED THE PATIENT TO HAVE A PSEUDO ANEURYSM WHICH REQUIRED A SURGICAL RESECTION TO CORRECT. THE PATIENT WAS REPORTED TO BE IN SATISFACTORY CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NMF NMF ASCENT HALTHCARE SOLUTIONS 11165 880274

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention