BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA IAB CATHETER KIT

    MDR report key: 4834630 · Received June 8, 2015

    Report

    Report Number
    2032677-2015-00014
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    April 8, 2014
    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

    DURING INTRA-AORTIC BALLOON (IAB) CATHETER TREATMENT, THE BALLOON REPORTEDLY RUPTURED AFTER TWO DAYS. THE CATHETER WAS REMOVED AND ANOTHER MANUFACTURER'S IAB CATHETER WAS USED FOR AN ADDITIONAL 15 DAYS. BASED ON PATIENT HEIGHT REPORTED, 155CM, THE MODEL IMU7F-40 IAB CATHETER WITH 40MM DIAMETER WAS TOO LARGE AND NOT THE CORRECT SIZE. EITHER AN IMUF7-35 OR IMU7F-30, WITH 35MM AND 30MM DIAMETER, RESPECTIVELY, SHOULD HAVE BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368450 ULTRA IAB CATHETER KIT INTRA-AORTIC BALLOON CATHETER DSP INSIGHTRA MEDICAL, INC. IMU7F-40 07171301

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention XENEX IAB CATHETER