BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: WEDGE 5 FR 60 CM

    MDR report key: 2193457 · Received July 13, 2011

    Report

    Report Number
    2242445-2011-00095
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYG
    PMA / PMN Number
    PREAMENDMENT
    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 ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE ANGIO ROOM AT PRETEST, THE BALLOON DID NOT INFLATE. THE KIT WAS NOT USED. THERE WAS NO DELAY OR PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: WEDGE 5 FR 60 CM BALLOON WEDGE PRESSURE CATHETER PRODUCTS DYG ARROW INTL., INC. MF1017643

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK