BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE STEELCORE 18 GUIDE WIRE WITH MICROGLIDE COATING

    MDR report key: 1162230 · Received September 16, 2008

    Report

    Report Number
    3004742046-2008-00219
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 25, 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 SECOND HI-TORQUE STEELCORE 18LT GUIDE WIRE (PART/LOT UNK) IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: GUIDE WIRE TIP UNRAVELED. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE IN THE POPLITEAL ARTERY, THE TIP OF THE STEELCORE GUIDE WIRE UNRAVELED AND WAS REMOVED FROM THE BODY. A SECOND STEELCORE GUIDE WIRE 300CM LONG WAS INSERTED. THIS WIRE APPEARED ABOUT TO UNRAVEL ALSO. THE WIRE WAS REMOVED FROM THE BODY AND 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 MICROGLIDE COATING DQX ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8041491

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STEELCORE