BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE

    MDR report key: 2083313 · Received April 13, 2011

    Report

    Report Number
    1649395-2011-00009
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Report Date
    April 4, 2011
    Manufacturer
    GALT MEDICAL CORP.
    Product Code
    DQX
    PMA / PMN Number
    K982559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EXAMINATION REVEALED THAT THE BALL END OF THE CORE WIRE BROKE DURING AN ATTEMPT TO REMOVE THE WIRE WHILE THE DISTAL TIP WAS CONSTRAINED BY SOMETHING HARD. THIS ALLOWED THE DISTAL TIP UNRAVEL FROM THE CORE WIRE. THE DISTAL TIP THEN REMAINED IN THE AREA OF THE TIP OF THE INSERTION DEVICE AS THE WIRE UNRAVELED. NO OUT OF SPEC CONDITIONS WERE NOTED DURING REVIEW OF PRODUCTION RECORDS. THE IFU PROVIDES SEVERAL WARNINGS ABOUT ATTEMPTING TO REMOVE THE GUIDE WIRE THROUGH THE NEEDLE, AND INSTRUCTS THE USER TO REMOVE THE GUIDE WIRE AND DILATOR TOGETHER, AND NOT TO REMOVE THE GUIDE WIRE SEPARATELY. ADDITIONAL LOT NUMBER: F0684910.

    Description of Event or Problem · 1

    (B)(4). THE WIRE WAS USED IN A PORT PLACEMENT AND BROKE OFF DURING PLACEMENT OF PORT IN LEFT SUBCLAVIAN ARTERY. THE WIRE DID NOT BREAK OFF INSIDE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDEWIRE NITINOL/STAINLESS STEEL GUIDEWIRE DQX GALT MEDICAL CORP. NA F0448910

    Patients

    Seq Age Sex Outcome Treatment
    1