BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY GUIDEWIRE

    MDR report key: 3053542 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05023
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 21, 2013
    Report Date
    July 31, 2013
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT THE MANUFACTURER'S QUALITY ASSURANCE LABORATORY, THIS PRODUCT WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION CONFIRMED THE GUIDEWIRE WAS KINKED ALONG THE BODY. ADDITIONALLY, THE DISTAL COIL WAS UNRAVELED AND THE COREWIRE WAS FRACTURED. THE FRACTURES OF THE COREWIRE WERE ANALYZED USING A SCANNING ELECTRON MICROSCOPE (SEM). IT WAS CONCLUDED THAT THE FRACTURE SITES WERE A RESULT OF TORSIONAL/SHEAR-FACE OVERLOAD. THE FRACTURES LIKELY OCCURRED DURING THE USE OF FORCE TO REMOVE THE PROLAPSED GUIDEWIRE. NO MANUFACTURING ISSUES WERE NOTED. ANALYSIS CONFIRMED THIS GUIDEWIRE BECAME DAMAGED WHEN IT WAS CAUGHT IN THE VESSEL AND REQUIRED SOME FORCE TO REMOVE IT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE, THIS GUIDEWIRE PROLAPSED AND BECAME LODGED BETWEEN THE SIDE OF THE VESSEL WALL AND THE SIDE OF THE LEAD. THE PHYSICIAN DID NOT WANT TO MOVE THE LEAD BACK AS FINDING AN ACCEPTABLE POSITION FOR THE LEAD HAD BEEN DIFFICULT. THE WIRE WAS VERY DIFFICULT TO REMOVE AND REQUIRED CONSIDERABLE FORCE TO PULL IT OUT OF THE VESSEL. VISUAL INSPECTION AFTER THE GUIDEWIRE WAS REMOVED NOTED THAT IT WAS FULLY STRIPPED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE GUIDEWIRE WILL BE RETURNED FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154870 ACUITY GUIDEWIRE DQX EXTERNAL MANUFACTURER 7081

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R