BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLO BALLOON GUIDE CATHETER

    MDR report key: 3173653 · Received June 17, 2013

    Report

    Report Number
    2029214-2013-00577
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 21, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER WAS EVALUATED AND THE BALLOON WAS NOT RUPTURED. THE BALLOON CATHETER WAS DAMAGED ON THE PROXIMAL SEGMENT AT THE CONNECTION POINT BETWEEN THE SHAFT AND THE CONNECTOR COVER; HOWEVER, THE CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS BEEN RECEIVED AND THE EVALUATION IS CURRENTLY IN PROGRESS. A FOLLOW UP WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON RUPTURED. THERE WAS ALSO A KINK IN THE CATHETER 5CM PROXIMAL OF THE DISTAL TIP. THE 035 GUIDEWIRE COULD NOT FIT THROUGH THE DILATOR AND THERE WAS A LEAK AT THE PROXIMAL END NEAR THE YELLOW SECTION OF THE HUB CAUSING BLOOD REFLUX IN THAT AREA. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274436 CELLO BALLOON GUIDE CATHETER GUIDE CATHETER DQY EV3 NEUROVASCULAR 1610590 5200162

    Patients

    Seq Age Sex Outcome Treatment
    1