BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 2193449 · Received July 13, 2011

    Report

    Report Number
    1219856-2011-00247
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ARROW INTL., 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). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED IN THE CATH LAB PRIOR TO INSERTION. THE INTRA-AORTIC BALLOON (IAB) FRACTURED WHILE THE MD WAS INSERTING THE CATHETER. HE FOLLOWED THE INSTRUCTIONS FOR USE EXACTLY, BUT HE COULD NOT INSERT THE CATHETER SMOOTHLY THEN FELT SOME RESISTANCE. HE HAD TO OPEN A NEW IAB KIT AND CONTINUED THE PROCEDURE WITH A NEW IAB. THERE ARE NO REPORTED PT INJURIES, COMPLICATIONS OR DEATH. THE INSERTION SITE WAS THE LEFT FEMORAL ARTERY. ADD'L INFO RECEIVED ON (B)(6) 2011 STATED THAT THE MIDDLE OF THE CATHETER FRACTURED WHILE THE PROCEDURE WAS IN PROCESS. THE MD HAD TO REMOVE THE SHEATH AND IAB CATHETER. HE LEFT THE SPRING WIRE GUIDE (SWG) IN PLACE AND USED THE TEFLON SHEATH. FOR THE SECOND INSERTION, HE USED A NEW SHEATH AND BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK