BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAM : 8 FR - 40 CC

    MDR report key: 4133015 · Received September 29, 2014

    Report

    Report Number
    1219856-2014-00187
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 1, 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 HAS BEEN REPORTED THAT WHILE IN THE CV-OR (CARDIOVASCULAR OPERATING ROOM) THE MD MET WITH DIFFICULTY INSERTING THE SPRING WIRE GUIDE (SWG) THROUGH THE "END OF THE CATHETER." THE SWG DIDN'T SLIDE THROUGH. THE MD STATED THAT THE EVENT OCCURRED WHILE THE IAB WAS INSIDE THE PATIENT. THE BALLOON NEVER DEPLOYED BECAUSE IT DID NOT GET PAST THE INTRODUCER SHEATH. THEY CORRECTED THE SITUATION BY REPLACING IT WITH THE SAME BRAND. AS A RESULT, THE IAB WAS NOT USED. A SECOND ARROW IAB WAS PREPPED AND USED FOR THIS PT. THERE WAS NO REPORTED PT DEATH, INJURY OR COMPLICATIONS. THERE WAS A 15 TO 30 MINUTE INTERRUPTION/DELAY IN IABP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606948 IAM : 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. 18F13K0054

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR