BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTS®

    MDR report key: 6614485 · Received June 6, 2017

    Report

    Report Number
    6614485
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    April 19, 2017
    Report Date
    April 26, 2017
    Manufacturer
    B BRAUN INTERVENTIONAL SYSTEMS, INC
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A MALE PATIENT WITH HISTORY OF BICUSPID AORTIC VALVE DISEASE STATUS POST ROSS PROCEDURE WITH RESULTING STENOTIC PULMONARY HOMOGRAFT ADMITTED FOR TRANSCATHETER PULMONARY VALVE REPLACEMENT. BALLOON SIZING OF THE PULMONARY ARTERY WITH DYNA CT PERFORMED WITH A 30 MM X 5 CM NUMED PERCUTANEOUS TRANSLUMINAL SIZING (PTS) SIZING BALLOON. BALLOON WAS ADVANCED INTO THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) AND MAIN PULMONARY ARTERY AND INFLATED UNDER RAPID PACING. THE BALLOON RUPTURED AT LOW PRESSURE REQUIRING REMOVAL OF 16F SHEATH AND REPLACEMENT WITH A 16F SHORT COOK SHEATH AND THE BALLOON WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS ABORTED AND RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394742 PTS® CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN B BRAUN INTERVENTIONAL SYSTEMS, INC 613704 OS-1739

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR