BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7FR - 30 CC

    MDR report key: 4120901 · Received July 28, 2014

    Report

    Report Number
    1219856-2014-00135
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED DURING INSERTION WHILE IN THE CATH LAB. INDICATION FOR USE: CARDIOGENIC SHOCK, THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB-S730C) THROUGH THE SUPER ARROW-FLEX (SAF) SHEATH WITHOUT ISSUE VIA THE PATIENT'S RIGHT SIDE. THE MD COULDN'T INFLATE THE IAB PERFECTLY EVENT THOUGH THE INSTRUCTIONS FOR USE WAS FOLLOWED EXACTLY: SAF SHEATH WITH KINKING ISSUE. AS A RESULT, THE MD REMOVED THE FAILED IAB AND SHEATH TOGETHER AS ONE UNIT SUCCESSFULLY. A NEW KIT WAS OPENED AND INSERTED VIA THE SAME INSERTION SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS PLANNED WITH THE SECOND KIT. THERE WAS NO REPORT OF PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS AN APPROXIMATE 10 MINUTE DELAY OR INTERRUPTION IN THERAPY WITH NO HARM TO PATIENT. UPDATED INFORMATION RECEIVED ON (B)(6) 2014 REPORTED THAT THERE WERE NO REPORT OF PATIENT COMPLICATIONS. THE PATIENT OUTCOME WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439797 IAB: 7FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. KF3015001

    Patients

    Seq Age Sex Outcome Treatment
    1