BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS

    MDR report key: 5091281 · Received September 21, 2015

    Report

    Report Number
    2183870-2015-00322
    Event Type
    Injury
    Date Received
    September 21, 2015
    Date of Event
    February 5, 2014
    Report Date
    March 28, 2014
    Manufacturer
    PLYMOUTH
    Product Code
    DQY
    PMA / PMN Number
    K110319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE EVERCROSS BALLOON WAS BEING USED TO TREAT RESTENOSIS. THE PATIENT UNDERWENT A SUCCESSFUL REVASCULARIZATION, HOWEVER A DISSECTION OCCURRED WHICH WAS TREATED BY PROLONGED POST-DILATATION. PATIENT WAS RELEASED FROM HOSPITAL WITHOUT POST INTERVENTIONAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622574 EVERCROSS CATHETER, PERCUTANEOUS DQY PLYMOUTH AB35W04080135V02 9650707

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention