BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBMARINE PLUS

    MDR report key: 2991160 · Received March 6, 2013

    Report

    Report Number
    3004066202-2013-00026
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    October 29, 2012
    Report Date
    October 30, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K042357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS AND CONCLUSION: (DISSECTION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN USED ONE SUBMARINE BALLOON CATHETER 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 BALLOON, A DISSECTION OCCURRED. DISSECTION WAS LEFT UNTREATED. PATIENT WAS DISCHARGED HOME THE NEXT DAY. INVESTIGATOR HAS NOT ASSESSED THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A SECOND BALLOON INFLATION WAS PERFORMED AFTER THE DISSECTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94846 SUBMARINE PLUS CATHETER, PERCUTANEOUS DQY INVATEC SPA 1D008385

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R CLOPIDOGREL AND ASPIRIN.