BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUATRACK HYDROPHILIC GUIDE WIRE

    MDR report key: 2012220 · Received February 2, 2011

    Report

    Report Number
    1625425-2011-00010
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    January 12, 2011
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF DEVICE INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN COMPLETE.

    Description of Event or Problem · 1

    THE HYDROPHILIC COATING OF THE AQUATRACK WIRE SHEARED OFF INTO THE PT. IT WAS A CAROTID PROCEDURE WITH GROIN ACCESS. THE ILIACS WERE TORTUOUS. THE PHYSICIAN ATTEMPTED A JWIRE THROUGH THE ACCESS NEEDLE BUT IT WOULD NOT GO. HE THEN PUT THE AQUATRACK THROUGH THE ACCESS NEEDLE; ADVANCED IT (ALTHOUGH THEY SAY THEY NEVER PULLED THE AQUATRACK BACK THROUGH THE NEEDLE); REMOVED THE NEEDLE; AND THEN DELIVERED A 6FX11 CM TERUMO SHEATH OVER THE AQUATRACK WIRE AND THEN PULLED THE AQUATRACK WIRE OUT AT WHICH POINT, THEY NOTICED THAT THE TIP OF THE WIRE HAD SHEARED OFF. THE PT HAD TO BE SENT TO SURGERY FOR REMOVAL OF THE SHEARED PORTION. THE WIRE IS AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUATRACK HYDROPHILIC GUIDE WIRE AQUATRACK GUIDE WIRE DQX ARGON MEDICAL DEVICES INC. NA 80001119

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention