BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA IAB CATHETER KIT

    MDR report key: 4834633 · Received June 8, 2015

    Report

    Report Number
    2032677-2015-00011
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    September 21, 2013
    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

    INTRA-AORTIC BALLOON (IAB) CATHETER WAS NOT ABLE TO BE PASSED THROUGH THE INTRODUCER SHEATH. THE INTRODUCER SHEATH AND CATHETER WERE REMOVED AND ANOTHER IAB CATHETER WAS USED SATISFACTORILY TO PROVIDE TREATMENT. THERE WAS NO PATIENT INJURY NOR WERE THERE ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368424 ULTRA IAB CATHETER KIT INTRA-AORTIC BALLOON CATHETER DSP INSIGHTRA MEDICAL, INC. IMUF7-40 03141201

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention