BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKET

    MDR report key: 6669245 · Received June 27, 2017

    Report

    Report Number
    6669245
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    June 20, 2017
    Report Date
    June 22, 2017
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    HFF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE 1ST CATHETER MD INSERTED CATHETER INTO THE PATIENT AND THE BALLOON WOULD NOT INFLATE. THE 2ND CATHETER MD INFLATED BALLOON PRIOR TO INSERTION AND INFLATED FINE. MD INSERTED CATHETER INTO THE PATIENT AND WAS NOT ABLE TO INFLATE THE BALLOON ONCE INSERTED. MD PULLED CATHETER OUT AND ATTEMPTED TO INFLATE THE BALLOON AND IT WOULD NOT INFLATE. THE MANUFACTURER IS CONTACTING THEIR QUALITY CONTROL DEPARTMENT TO INVESTIGATE AND HAVE REQUESTED TO SEND BACK THE INVENTORY AND DEFECTIVE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451700 ROCKET SONOHYSTOGRAM CATHETER HFF ROCKET MEDICAL PLC R57422 468380

    Patients

    Seq Age Sex Outcome Treatment
    1