BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9F PRUITT OUTLYING F3 SHUNT WITH T-PORT

    MDR report key: 4759800 · Received May 4, 2015

    Report

    Report Number
    1220948-2015-00003
    Event Type
    Malfunction
    Date Received
    May 4, 2015
    Report Date
    April 9, 2015
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    MJN
    PMA / PMN Number
    K051067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION AND WERE ABLE TO CONFIRM THE FAILURE. THE INTERNAL CAROTID BALLOON WOULD NOT DEFLATE - THE BALLOON DEFLATED UNEVENLY AND A PORTION OF THE BALLOON COVERED THE INFLATION HOLES WHILE SOME AMOUNT OF THE SALINE WAS STILL IN THE BALLOON (TRAPPED). WE HAVE INITIATED AN INTERNAL CORRECTIVE AND PREVENTIVE ACTION TO INVESTIGATE THIS ISSUE FURTHER (PLEASE REFERENCE LEMAITRE VASCULAR INC. CAPA (B)(4)). PLEASE NOTE NO PATIENT INJURIES HAPPENED DUE TO THIS INCIDENT.

    Description of Event or Problem · 1

    SURGEON PERFORMED A CAROTID ENDARTERECTOMY PROCEDURE. THE INTERNAL CAROTID BALLOON WOULD INFLATE, BUT WOULD NOT DEFLATE ENTIRELY AT THE END OF THE PROCEDURE. THE ENDARTERECTOMY WAS COMPLETED. NO PATIENT INJURY HAPPENED DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292473 9F PRUITT OUTLYING F3 SHUNT WITH T-PORT PRUITT F3 SHUNT MJN LEMAITRE VASCULAR E2012-10 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other