BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANCE HANDPIECE

    MDR report key: 5835081 · Received July 29, 2016

    Report

    Report Number
    3006443171-2016-00004
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    July 5, 2016
    Report Date
    July 29, 2016
    Manufacturer
    HALT MEDICAL, INC.
    Product Code
    HFG
    PMA / PMN Number
    K121858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS SHOWED NO EVIDENCE OF A MANUFACTURING PROBLEM WITH THE DEVICE. EVIDENCE SHOWED THAT THE HANDPIECE WAS ROTATED/ADVANCED WHILE THE NEEDLES WERE DEPLOYED CAUSING A SHARP BEND ON THE CENTER NEEDLE. RETRACTING THE ARRAY MAY HAVE CAUSED THE CENTER NEEDLE TO BREAK. AN X-RAY TAKEN OF THE PATIENT DID NOT IDENTIFY THE PRESENCE OF A NEEDLE FRAGMENT.

    Description of Event or Problem · 1

    AN ELECTRODE FROM THE GUIDANCE HANDPIECE (MODEL NUMBER 5300, LOT NUMBER T160407) BROKE DURING THE PROCEDURE AT (B)(6) HOSPITAL WITH DR. (B)(6). THE EVENT OCCURRED DURING HANDPIECE PLACEMENT INTO A 5CM FIBROID THAT THE DOCTOR CONSIDERED TOUGH. THE DR. DEPLOYED (1.5CM) AND FELT RESISTANCE. WHILE RETRACTING THE ARRAY, THE DR. HAD DIFFICULTY AND STATED HE FELT A SNAP. THIS OCCURRED AFTER THE 11TH ABLATION. THE HANDPIECE WAS WITHDRAWN FROM THE PATIENT FOR INSPECTION AND IT WOULD NOT DEPLOY PAST 1.5CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485996 GUIDANCE HANDPIECE GUIDANCE HANDPIECE HFG HALT MEDICAL, INC. 5300 160407

    Patients

    Seq Age Sex Outcome Treatment
    1