BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB : 8 FR - 30 CC FOS

    MDR report key: 2141173 · Received June 22, 2011

    Report

    Report Number
    1219856-2011-00217
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) FIBEROPTIX SENSOR (FOS) WAS NOT RECOGNIZED BY THE PUMP. THE PHYSICIAN UTILIZED THE IAB USING ON THE ECG INPUT. WHEN REMOVING THE IAB, WHICH WAS IN USE FOR 77 HOURS, THE IAB COULD NOT BE REMOVED THROUGH THE TEFLON SHEATH. AS A RESULT, THE IAB HAD TO BE SURGICALLY REMOVED FROM THE RIGHT FEMORAL ARTERY BECAUSE THERE WAS A BLOOD CLOT APPROXIMATELY 2CM IN SIZE AT THE TIP OF THE BALLOON WHICH CAUSED THE BALLOON TO BECOME STUCK AT THE TIP OF THE SHEATH. THE PATIENT HAD ALREADY BEEN UNCONSCIOUS WHEN THE IAB WAS INSERTED AND REMAINED UNCONSCIOUS. THE PATIENT HAS NO TORTUROUS VESSEL OR CALCIFICATION. DURING THE INTRA-AORTIC BALLOON PUMP (IABP) TREATMENT, THE PUMP DID NOT ALARM SO THE PHYSICIAN DID NOT NOTICE THE BLOOD CLOT UNTIL ATTEMPTING TO REMOVE THE IAB. (B)(6) NOTED THAT THE IAB WAS PREPARED PER INSTRUCTION. THERE WAS NO REPORTED DEATH OR COMPLICATIONS AS A RESULT. ADDITIONAL INFORMATION RECEIVED FROM (B)(6) STATED THAT HEPARINIZED SALINE WAS USED IN THE LINES OF THE IAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. KF1029237

    Patients

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