BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 4152495 · Received October 6, 2014

    Report

    Report Number
    1219856-2014-00191
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INDICATION FOR INTRA-AORTIC BALLOON PUMP (IABP) THERAPY WAS PRE-OP IABP INSERTION FOR CABG (CORONARY ARTERY BYPASS GRAFT). WHILE IN THE CATH LAB THE MD INSERTED THE SHEATH INTO THE PT'S LEFT FEMORAL ARTERY. DURING INSERTION OF THE INTRA-AORTIC BALLOON (IAB), THE MEMBRANE UNRAVELED. THE MD TRIED TO PULL NEGATIVE PRESSURE; ATTEMPTING TO DEFLATE THE MEMBRANE WITHOUT SUCCESS. AS A RESULT, ANOTHER IAB WAS RETRIEVED. THERE WAS A 10 TO 20 MINUTE DELAY / INTERRUPTION IN IABP THERAPY. THE DELAY / INTERRUPTION DID NOT CAUSE HARM TO THE PT. THERE WERE NO REPORTED PT COMPLICATIONS. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL / SURGICAL INTERVENTION WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622273 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. 18F13K0054

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR