BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC

    MDR report key: 2102956 · Received May 4, 2011

    Report

    Report Number
    1219856-2011-00158
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 WHILE IN THE CARDIO CATH LAB DURING A PROCEDURE, THE MD COULD NOT ADVANCE THE CATHETER DUE TO SEVERE RESISTANCE UPON INSERTION. AS A RESULT, THE MD REMOVED THE FAILED CATHETER AND REPLACED IT WITH A NEW CATHETER. PER THE MD THERE WAS NO EXCESSIVE BLEEDING AND THE MD USED THE SAME INSERTION SITE (LEFT FEMORAL ARTERY) DURING THIS PROCEDURE. THERAPY WAS DELAYED FOR 10 MINUTES. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. THE PT OUTCOME IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK