BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILTRAC .018 PERIPHERAL DILATATION CATHETER

    MDR report key: 1067045 · Received June 26, 2008

    Report

    Report Number
    3004742046-2008-00153
    Event Type
    Malfunction
    Date Received
    June 26, 2008
    Date of Event
    May 7, 2008
    Report Date
    June 2, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THE DEVICE #1, AGILTRAC PART# 1010061-100, LOT# 8040851 IS BEING FILED UNDER MEDWATCH MANUFACTURER. # 3004742046-2008-00151.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #2, BALLOON RUPTURE. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE IN AN UNSPECIFIED, SEVERELY CALCIFIED VESSEL THE AGILTRAC BALLOON RUPTURED AT 3-4 ATM, BELOW RATED BURST PRESSURE, DURING THE FIRST INFLATION. THE BALLOON WAS ENTIRELY REMOVED WITHOUT DIFFICULTY. A SECOND AGILTRAC BALLOON WAS ATTEMPTED WITH THE SAME RESULTS. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILTRAC .018 PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 6071752

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DEVICE #1: AGILTRAC DILATATION CATHETER| LOT# 8040851| PART# 1010061-100