BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5161332

    MDR report key: 5161332 · Received October 20, 2015

    Report

    Report Number
    5161332
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 28, 2015
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME INTO THE HOSPITAL WITH A ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) AND WAS IN CARDIOGENIC SHOCK. MD INSERTED AN INTRODUCER FOR AN IMPELLA (LEFT VENTRICULAR ASSIST DEVICE). MD REPORTED TO CATH LAB MANAGER THAT HE'D HAD DIFFICULTY WITH INSERTION. HE REPORTED THAT THE PROBLEM WITH INSERTION IS THAT THE TRANSITION FROM THE DILATOR TO THE SHEATH IS NOT SMOOTH. IT IS DESCRIBED AS "SHOULDERING" OR HITTING A SPEED BUMP. SPECIFICALLY, THE SHEATH BULGES AT TRANSITION TO THE DILATOR, WHICH MAKES IT DIFFICULT TO INSERT.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR