BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9F PRUITT OUTLYING F3 SHUNT WITH T-PORT

    MDR report key: 2498569 · Received January 27, 2012

    Report

    Report Number
    1220948-2012-00002
    Event Type
    Malfunction
    Date Received
    January 27, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 3, 2012
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    MJN
    PMA / PMN Number
    K051067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR THE EVALUATION ON (B)(6) 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 INVESTIGATING NEW METHODS FOR INSTALLING THE BALLOONS ON CATHETERS (PLEASE REFERENCE LEMAITRE VASCULAR INC. CORRECTIVE ACTION CAPA (B)(4)). WE BELIEVE THAT THESE STEPS WILL PREVENT THIS PROBLEM FROM REOCCURRING. PLEASE NOTE THAT NO PATIENT INJURIES HAPPENED DUE TO THIS INCIDENT.

    Description of Event or Problem · 1

    AT THE END OF PROCEDURE THE PHYSICIAN COULD NOT DEFLATE THE COMMON BALLOON ON THE SHUNT. THE PHYSICIAN CUT THE COMMON ARM (LUMEN) OF THE DEVICE, BUT THE BALLOON REMAINED INFLATED. THE DEVICE WAS PULLED FROM A PATIENT IN THE INFLATED STATE. 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 PFT2268

    Patients

    Seq Age Sex Outcome Treatment
    1