BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA IAB CATHETER KIT

    MDR report key: 4834629 · Received June 8, 2015

    Report

    Report Number
    2032677-2015-00015
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    August 20, 2014
    Report Date
    June 8, 2015
    Manufacturer
    INSIGHTRA MEDICAL, INC.
    Product Code
    DSP
    PMA / PMN Number
    K082746
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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

    INTRA-AORTIC BALLOON (IAB) CATHETER WAS BEING USED FOR TREATMENT. DURING MYOCARDIAL REVASCULARIZATION, THE BALLOON DID NOT INFLATE. THERE WERE NO ALARMS FROM THE PUMP CONSOLE. THE IAB CATHETER WAS REMOVED AND ANOTHER IAB CATHETER WAS USED TO TREAT THE PATIENT AND NO PROBLEMS WERE REPORTED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368973 ULTRA IAB CATHETER KIT NONE DSP INSIGHTRA MEDICAL, INC. IMU7F-35 07181302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention