BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER RECANALIZATION CATHETER

    MDR report key: 1945212 · Received December 10, 2010

    Report

    Report Number
    2020394-2010-00358
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K091119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO ASSOCIATED NONCONFORMING MATERIALS. BASED ON THE EVENT DESCRIPTION AND RESULTS OF MFG CONTROLS, NO OBJECTIVE EVIDENCE WAS FOUND TO LINK THE EVENT TO MFG. THE LOT MET ALL RELEASE CRITERIA. THE COMPLAINT SAMPLE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A RECANALIZATION CATHETER DETACHED FROM THE CATHETER WHILE THE DEVICE WAS BEING WITHDRAWN FROM THE POSTERIOR TIBIAL ARTERY. AN ATTEMPT WAS MADE TO IMPLANT TO STENT TO SECURE THE TIP AGAINST THE VESSEL WALL; HOWEVER, THE GUIDEWIRE WENT SUBINTIMAL AND ACCESS TO THE TREATMENT VESSEL WAS LOST. THEREFORE, THE STENT COULD NOT BE IMPLANTED. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSER RECANALIZATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. FCUI10010

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR