BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB : 8 FR - 40 CC

    MDR report key: 633087 · Received August 31, 2005

    Report

    Report Number
    1219856-2005-00212
    Event Type
    Injury
    Date Received
    August 31, 2005
    Date of Event
    August 18, 2005
    Report Date
    August 29, 2005
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IAB WAS INSERTED FEMORALLY VIA SHEATH ON 08/2005. THE PT BECAME AGITATED AND INTUBATED. HANDS AND LEFT LEG WERE RESTRAINED. IN 08/2005, PT ATTEMPTED TO PULL IAB OUT. IABP IMMEDIATELY EXPERIENCED ALARMS AND BLOOD WAS OBSERVED IN TUBING. IAB WAS CLAMPED AND IABP SHUT OFF. CARDIOLOGIST CUT IAB AS HE COULD NOT REMOVED IT THROUGH SHEATH. VASCULAR SURGERY WAS PERFORMED TO REMOVE IAB AND REPAIR FEMORAL ARTERY. RE-INSERTION NOT REQUIRED. NO ASSOCIATED PT COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IAB WAS INSERTED FEMORALLY VIA SHEATH IN 2005. THE PT BECAME AGITATED AND INTUBATED. HANDS AND LEFT LEG WERE RESTRAINED. A WEEK LATER, PT ATTEMPTED TO PULL IAB OUT. IABP IMMEDIATELY EXPERIENCED ALARMS AND BLOOD WAS OBSERVED IN TUBING. IAB WAS CLAMPED AND IABP SHUT OFF. CARDIOLOGIST CUT IAB AS HE COULD NOT REMOVE IT THROUGH SHEATH. VASCULAR SURGERY WAS PERFORMED TO REMOVE IAB AND REPAIR FEMORAL ARTERY. RE-INSERTION NOT REQUIRED. NO ASSOCIATED PT COMPLICATIONS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention