BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1870976 · Received October 8, 2010

    Report

    Report Number
    1219856-2010-00699
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN PLACED A SUPER ARROW-FLEX (SAF) SHEATH IN THE LEFT FEMORAL ARTERY. THEN THE WELL PREPARED INTRA-AORTIC BALLOON (IAB) WAS INSERTED OVER THE SPRING WIRE GUIDE (SWG) WHEN IT BECAME STUCK AT THE MID RANGE IN THE SAF SHEATH. THE PHYSICIAN COULD NOT MOVE THE BALLOON OR SWG FORWARD OR BACKWARD. THE PHYSICIAN REMOVED THE SAF SHEATH, BALLOON AND SWG FORWARD OR BACKWARD. THE PHYSICIAN REMOVED THE SAF SHEATH, BALLOON AND SWG FOR THE LEFT FEMORAL ARTERY. THE PHYSICIAN SWITCHED TO THE RIGHT FEMORAL ARTERY, OPENED A NEW IAB AND AGAIN THE BALLOON BECAME STUCK AT 1/3 OF THE SAF RANGE. THERE WAS NO REPORTED PT DEATH, INJURIES OR COMPLICATIONS. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PT WAS BEING PUMPED CORRECTLY FROM THE AUGMENTED PRESSURES. REFERENCE MDR #1219856-2010-00700 FOR THE SECOND EVENT INVOLVING THE SAME 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. MF9100025

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other INTRA-AORTIC BALLOON PUMP