BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBMARINE PLUS

    MDR report key: 2982577 · Received February 28, 2013

    Report

    Report Number
    3004066202-2013-00019
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 28, 2012
    Report Date
    March 24, 2016
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K042537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS AND CONCLUSIONS: INHERENT RISK OF PROCEDURE - (DISSECTION). (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IS AN EX-SMOKER.

    Description of Event or Problem · 1

    TWO SUBMARINE PLUS PTA BALLOON CATHETERS WERE USED TO TREAT A LESION LOCATED IN THE SFA OF THE RIGHT LEG. DEVICE WAS SUCCESSFUL; HOWEVER, IT WAS REPORTED THAT DURING TREATMENT WITH THE SUBMARINE PLUS PTA BALLOONS, A DISSECTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89043 SUBMARINE PLUS CATHETER, PERCUTANEOUS DQY INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R CLOPIDOGREL AND ASPIRIN.