BEUDAMED
    FDA Adverse Event Other Summary report: N

    TREX MEDICAL

    MDR report key: 840135 · Received April 11, 2007

    Report

    Report Number
    1221300-2007-00002
    Event Type
    Other
    Date Received
    April 11, 2007
    Date of Event
    January 16, 2007
    Report Date
    April 10, 2007
    Manufacturer
    TREX MEDICAL - HOLOGIC, INC.
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS SHIPPED TO THE CUSTOMER, THE DEVICE HAS NOT BEEN SERVICED BY HOLOGIC. HOLOGIC CONTACTED RPTR TO OBTAIN INFO CONCERNING THE DEVICE. RPTR INFORMED HOLOGIC THAT THE DEVICE WAS SERVICED BY THE MEDICAL CENTER'S MAINTENANCE DEPARTMENT AND WAS PERFORMING IN ACCORDANCE WITH THE MANUFACTURER'S SPECIFICATIONS. RPTR ALSO STATED THAT THE EVENT WAS NOT RELATED TO A FAILURE OF THE DEVICE. BASED ON THE INFO RECEIVED, HOLOGIC IS NOT TAKING ANY FURTHER ACTION.

    Description of Event or Problem · 1

    HOLOGIC RECEIVED A REPORT FROM A MEDICAL CENTER INDICATING THAT THE LISTED DEVICE WAS USED ON A PEDIATRIC PT DURING INTERVENTIONAL CARDIAC CATHETERIZATION. DURING THE PROCEDURE, IT WAS NECESSARY TO USE PROLONGED FLUOROSCOPY AND DIGITAL CINE ACQUISITION. THE PT APPEARED TO SUFFER A RADIATION BURN AND IT WAS DETERMINED THAT IT WAS DUE TO THE PROLONGED FLUOROSCOPY TIME. THE PT UNDERWENT TWO ADDITIONAL INTERVENTIONAL CARDIAC CATHETERIZATION PROCEDURES. THE PT EXPIRED 20 DAYS LATER AS A RESULT OF COMPLICATIONS UNRELATED TO THE SKIN BURN. MEDICAL INTERVENTION TO THE BURNT AREA, OTHER THAN TOPICAL TREATMENT, WAS NOT PERFORMED. THE REPORT STATED THAT THERE WERE NO EQUIPMENT OR OPERATOR RELATED PROBLEMS ASSOCIATED WITH THIS EVENT. THE EXTENDED USE OF FLUOROSCOPY AND DIGITAL CINE ACQUISITION WAS NEEDED TO COMPLETE REQUIRED MEDICAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREX MEDICAL UNICATH - PEDIATRIC BI-PLANE CATH LAB JAA TREX MEDICAL - HOLOGIC, INC. SP BI - PLANE *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Required Intervention