BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9F PRUITT OUTLYING F3 SHUNT WITH T-PORT

    MDR report key: 2516063 · Received March 30, 2012

    Report

    Report Number
    1220948-2012-00007
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    MJN
    PMA / PMN Number
    K051067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR THE EVALUATION ON (B)(4) 2012. WE WERE ABLE TO VERIFY AND CONFIRM THE FAILURE. WE HAVE FOUND THAT THE COMMON BALLOON WOULD NOT DEFLATE PROPERLY. AS A RESULT OF SIMILAR COMPLAINT, WE HAVE INITIATED IMPROVEMENTS IN OUR BALLOON MANUFACTURING PROCESS: WE HAVE RETRAINED OUR ASSEMBLERS; CLARIFIED OUR MANUFACTURING INSTRUCTIONS, AND, WE ARE INVESTING NEW METHODS FOR INSTALLING THE BALLOONS ON CATHETERS ((B)(4)). WE BELIEVE THAT THESE STEPS WILL PREVENT THIS PROBLEM FROM REOCCURRING. PLEASE NOTE THAT NO PT INJURIES HAPPENED DUE TO THIS INCIDENT.

    Description of Event or Problem · 1

    AT THE END OF THE PROCEDURE THE PHYSICIAN COULD NOT DEFLATE THE COMMON BALLOON ON THE SHUNT. THE SURGEON HAD TO USE A 10 CC SYRINGE TO DEFLATE THE BALLOON. NO PT 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 PFT2228

    Patients

    Seq Age Sex Outcome Treatment
    1