BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9F PRUITT OUTLYING F3 SHUNT WITH T-PORT

    MDR report key: 3145461 · Received May 24, 2013

    Report

    Report Number
    1220948-2013-00008
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 10, 2013
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    MJN
    PMA / PMN Number
    K051067
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE DEVICE FOR THE EVALUATION, BUT WE WERE NOT ABLE TO CONFIRM OR VERIFY THE FAILURE MODE. ALL BALLOONS WERE FUNCTIONAL AND PERFORMED AS EXPECTED. NO PROBLEMS FOUND. LOT HISTORY RECORDS REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT EITHER DURING THE MANUFACTURING OR PACKAGING PROCESSES. ALL MANUFACTURING AND QC STEPS WERE COMPLETED IN ACCORDANCE TO MANUFACTURING INSTRUCTIONS. THEREFORE THE ROOT CAUSE(S) OF THE FAILURE REMAINS INCONCLUSIVE. HOWEVER, LEMAITRE VASCULAR, INC. HAS INITIATED CORRECTIVE AND PREVENTIVE ACTION (PLEASE REFERENCE LEMAITRE CAPA (B)(4)) TO IMPROVE BALLOON CONCENTRICITY AND DEFLATION TIME. PLEASE NOTE THAT NO PATIENT INJURY HAPPENED DURING THIS INCIDENT.

    Description of Event or Problem · 1

    THE COMMON BALLOON WOULD NOT DEFLATE AT THE END OF THE PROCEDURE. THE PHYSICIAN WAS ABLE TO SAFELY REMOVE BALLOON FROM THE PATIENT. NO PATIENT INJURY HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230563 9F PRUITT OUTLYING F3 SHUNT WITH T-PORT PRUITT F3 SHUNT MJN LEMAITRE VASCULAR 2012-10 PFT2461

    Patients

    Seq Age Sex Outcome Treatment
    1 Other