BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9F PRUITT OUTLYING F3 SHUNT WITH T-PORT

    MDR report key: 2971944 · Received January 21, 2013

    Report

    Report Number
    1220948-2013-00001
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    MJN
    PMA / PMN Number
    K051067
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR THE EVALUATION (THE DEVICE WAS DISCARDED BY THE USER AFTER THE PROCEDURE). THEREFORE, WE WERE NOT ABLE TO VERIFY THE FAILURE MODE. 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. THE ROOT CAUSE(S) OF THE FAILURE REMAINS INCONCLUSIVE. PLEASE NOTE THAT NO PT INJURY HAPPENED.

    Description of Event or Problem · 1

    THE BALLOON WOULD NOT DEFLATE AT THE END OF THE PROCEDURE. THE PHYSICIAN HAD TO CUT THE DEVICE TO DEFLATE THE BALLOON. NO PT INJURY HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28937 9F PRUITT OUTLYING F3 SHUNT WITH T-PORT PRUITT F3 SHUNT MJN LEMAITRE VASCULAR 2012-10 PFT2372

    Patients

    Seq Age Sex Outcome Treatment
    1 Other