BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: THERMISTOR 6 110CM

    MDR report key: 2243865 · Received August 24, 2011

    Report

    Report Number
    2242445-2011-00113
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYG
    PMA / PMN Number
    K833572
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE CATH LAB WITH NO PT INVOLVEMENT. DURING PRETEST, THE BALLOON WOULD NOT INFLATE. AS A RESULT, THE CATHETER WAS NOT USED. A NEW KIT WAS OPENED AND USED SUCCESSFULLY. NO DELAY OR INTERRUPTION IN THERAPY NOTED. NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. THE PT'S OUTCOME IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: THERMISTOR 6 110CM BALLOON THERMODILUTION CATHETER PRODUCTS DYG ARROW INTERNATIONAL INC. MF1027877

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK