BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILTRAC .035 PERIPHERAL DILATATION CATHETER

    MDR report key: 1061138 · Received June 13, 2008

    Report

    Report Number
    3004742046-2008-00139
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE AGILTRAC, LOT# 7092551, IS BEING FILED UNDER THE SAME MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE OF THE ILIAC ARTERY, THE AGILTRAC BALLOON RUPTURED AT UNSPECIFIED ATM. THE CATHETER WAS REMOVED FROM THE ANATOMY WITHOUT INCIDENT AND A SECOND AGILTRAC WAS USED WITH THE SAME RESULTS. AFTER DELIVERY CATHETER REMOVAL, AN OMNILINK WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILTRAC .035 PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 6111351

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT# 7092551| AGILTRAC DILATATION CATHETER