BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA IAB CATHETER KIT

    MDR report key: 4834649 · Received June 8, 2015

    Report

    Report Number
    2032677-2015-00001
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    December 13, 2010
    Report Date
    June 8, 2015
    Manufacturer
    INSIGHTRA MEDICAL, INC.
    Product Code
    DSP
    PMA / PMN Number
    K082746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR WAS PREPARED BASED ON A 483 OBSERVATION DURING AN FDA INSPECTION FROM (B)(6) 2015 AND RETROSPECTIVE REVIEW OF CUSTOMER COMPLAINTS.

    Description of Event or Problem · 1

    AN INTRA-AORTIC BALLOON (IAB) CATHETER WAS BEING USED FOR TREATMENT. USER REPORTED THAT THE CATHETER HAD BEEN USED FOR 36 HRS AND THE PUMP CONSOLE BEGAN TO ALARM. THE CATHETER WAS REMOVED AND THE BALLOON APPEARED TO BE SATISFACTORY. DAMAGE TO THE CATHETER BODY WAS OBSERVED. THE TREATMENT WAS CONTINUED WITH ANOTHER MANUFACTURER'S IAB CATHETER. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367270 ULTRA IAB CATHETER KIT NONE DSP INSIGHTRA MEDICAL, INC. IMU7F-40 04130901

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention