BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 2193272 · Received July 13, 2011

    Report

    Report Number
    1219856-2011-00250
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 13, 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. THE PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR USE, BUT FAILED TO DELIVER THE INTRA-AORTIC BALLOON (IAB) CATHETER TO THE RIGHT POSITION. HE HAD DIFFICULTY ADVANCING THE CATHETER DUE TO SEVERE RESISTANCE. HE REMOVED THE CATHETER AND REPLACED IT WITH A NEW ONE. THERE WAS NO EXCESSIVE BLEEDING AND THE PHYSICIAN USED THE SAME INSERTION SITE, LEFT FEMORAL ARTERY, FOR BOTH INSERTIONS. ADD'L INFO RECEIVED ON (B)(4) 2011 FROM THE DISTRIBUTOR INDICATED THAT IT WAS THE TEFLON SHEATH THAT WAS BEING USED. DUE TO DIFFICULTY ADVANCING THE CATHETER, IT WAS REMOVED ALONG WITH THE SHEATH. THE SPRING WIRE GUIDE (SWG) WAS KEPT IN PLACE. A 5 MINUTE DELAY WAS NOTED WITH NO INJURIES OR COMPLICATIONS TO THE PT.

    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