BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9F PRUITT OUTLYING F3 SHUNT WITH T-PORT

    MDR report key: 2917876 · Received December 20, 2012

    Report

    Report Number
    1220948-2012-00023
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    MJN
    PMA / PMN Number
    K051067
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR THE EVALUATION AND, WE WERE ABLE TO CONFIRM THE FAILURE. WE FOUND THAT THE BLUE STOPCOCK ON THE SHUNT WAS LEAKING AT THE BUSHING. THE MOST PROBABLE ROOT CAUSE OF LEAKING IS THE OPERATOR ERROR ¿ NOT ENOUGH GLUE WAS APPLIED DURING THE MANUFACTURING PROCESS. THE DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING EITHER THE MANUFACTURING OR THE PACKAGING PROCESSES. WE HAVE INITIATED CORRECTIVE AND PREVENTIVE ACTION (PLEASE REFERENCE LEMAITRE VASCULAR, INC. CAPA (B)(4)) TO ADDRESS THIS ISSUE IN MORE DETAILS. WE DID MAKE OUR MANUFACTURING ASSOCIATES AWARE OF THIS PROBLEM AND RE-TRAINED THEM. PLEASE NOTE THAT ALL OUR DEVICES ARE 100% LEAK (INFLATION) TESTED BEFORE THE SHIPPING. HOWEVER, WE ARE INVESTIGATING LEAK TEST METHODS. PLEASE NOTE THAT NO PATIENT INJURY HAPPENED.

    Description of Event or Problem · 1

    SHUNT FAILED WHILE SURGEON WAS SEWING IN PATCH AT THE END OF THE PROCEDURE, BUT WORKED UP UNTIL THAT POINT. A BLUE COMMON BALLOON KEPT SLIPPING OUT OF THE ARTERY. THE PHYSICIAN FOUND A LEAK RIGHT BETWEEN BLUE STOPCOCK WHERE THE SYRINGE WAS ATTACHED AND TUBING. SHUNT WORKED PROPERLY DURING PRE USE TEST AND THEN THE FIRST HALF OF THE PROCEDURE. PATIENT SAFETY WAS COMPROMISED DUE TO PROLONGED PROCEDURE: THEY HAD TO CLAMP FOR 10 MINUTES AND THEN ANOTHER 3 MINUTES. HOWEVER, NO PATIENT INJURY HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9F PRUITT OUTLYING F3 SHUNT WITH T-PORT PRUITT F3 SHUNT MJN LEMAITRE VASCULAR 2012-10 PFT2198

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R