BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMA BERENSTEIN CATHETER

    MDR report key: 2013813 · Received February 4, 2011

    Report

    Report Number
    1628221-2011-00002
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K000659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED. THE WHITE TIP OF THE CATHETER HAD PARTIALLY TORE FROM THE CATHETER SHAFT AT THE FUSE ZONE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NO EXCEPTION DOCUMENTS. THE COMPLAINT DATA BASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE WAS EXAMINED VISUALLY UNDER MAGNIFICATION AND FOUND TO HAVE AN UNUSUAL PROCESSING DEFECT THAT DID NOT ALLOW FOR SUFFICIENT HEAT TRANSFER TO FORM A FULL PERMANENT BOND BETWEEN THE CATHETER TIP AND BODY. DEVICE EVALUATION: METHOD: THE DEVICE HISTORY RECORD WAS REVIEWED, THE COMPLAINT DATA BASE WAS REVIEWED. RESULTS: CATHETER.

    Description of Event or Problem · 1

    WHILE CANNULATING THE OSTIUM OF THE LEFT CAROTID ARTERY VIA FEMORAL ACCESS, THE CATHETER TIP PARTIALLY TORE FROM THE CATHETER SHAFT WHILE TORQUING THE CATHETER IN THE TORTUOUS ANATOMY OF THE PATIENT. NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMA BERENSTEIN CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. E144564

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA| .035 GUIDEWIRE| SALINE