BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 6 FR 9 0CM

    MDR report key: 2192832 · Received July 20, 2011

    Report

    Report Number
    2242445-2011-00100
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    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 THE BALLOON WAS PRETESTED IN THE CATH LAB WITHOUT ISSUE. HOWEVER, AFTER THE BALLOON WAS INSERTED THROUGH THE SHEATH INTO THE PT'S LEFT FEMORAL VEIN, THE DOCTOR WAS UNABLE TO INFLATE THE BALLOON. AS A RESULT, A NEW PRODUCT WITH THE SAME CODE WAS OPENED AND THE DIAGNOSTIC PROCEDURE WAS PERFORMED AS PLANNED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: BERMAN 6 FR 9 0CM BERMAN ANGIOGRAPHIC CATHETER PRODUCTS DQO ARROW INTL., INC. MF0126691

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK