BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE STEELCORE 18 GUIDE WIRE WITH MICROGLID COATING

    MDR report key: 1157768 · Received September 10, 2008

    Report

    Report Number
    3004742046-2008-00210
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    DQX
    PMA / PMN Number
    K980119
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. THE FIRST STEELCORE GUIDE WIRE (PART 1003282, LOT 8040891) IS FILED UNDER MFR# 3004742046-2008-00209.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #2: GUIDE WIRE TIP UNREVEALED. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE IN THE POPLITEAL ARTERY, A GAP IN THE TIP OF THE STEELCORE GUIDE WIRE WAS SEEN FLUOROSCOPICALLY. AFTER THE DEVICE WAS REMOVED AND INSPECTED, IT WAS NOTICED THAT THE TIP OF THE GUIDE WIRE WAS UNRAVELED. A SECOND STEELCORE GUIDE WIRE WAS INSERTED AND THE TIP OF THIS WIRE UNRAVELED ALSO. THE PROCEDURE WAS COMPLETED USING A THIRD, NON-ABBOTT GUIDE WIRE. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE STEELCORE 18 GUIDE WIRE WITH MICROGLID COATING DQX ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8040891

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STEELCORE GUIDE WIRE: (LOT 8040891)