BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRO CHOLANGIOGRAPHY SE T

    MDR report key: 2241178 · Received August 17, 2011

    Report

    Report Number
    2242445-2011-00106
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    GBZ
    PMA / PMN Number
    K905229
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO INSERTION, THEY TESTED THE BALLOON AND IT WOULD NOT INFLATE. AS A RESULT, ANOTHER KIT WAS OPENED AND USED SUCCESSFULLY FOR THE PT. THERE WAS A FEW MINUTES DELAY IN TREATMENT TO OBTAIN ANOTHER KIT. THERE WAS NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRO CHOLANGIOGRAPHY SE T CHOLANGIOGRAPHY CATHETER PRODUCTS GBZ ARROW INTERNATIONAL INC MF0063488

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK