BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM

    MDR report key: 1882325 · Received October 21, 2010

    Report

    Report Number
    2183502-2010-00470
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 19, 2010
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC.)
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. VISUAL EXAMINATION CONFIRMED THAT THE GUIDEWIRE HAD BEEN STRETCHED WHICH WAS FOUND TO BE A RESULT OF BREAKAGE OF THE INTERNAL STIFFENER WIRE. THE WIRE HAD BEEN BROKEN 8 MM FROM THE HANDLE. NO EVIDENCE WAS FOUND TO SUGGEST THE REPORTED EVENT WAS CAUSED BY AN INTRINSIC DEFECT IN THE PRODUCT. THE DAMAGE SEEN IS CONSISTENT WITH EXCESSIVE TENSILE LOADING DURING USE.

    Description of Event or Problem · 1

    PER THE REPORTER, THE PHYSICIAN EXPERIENCED DIFFICULTY DURING IMPLANT OF THE INTRASPINAL CATHETER. DURING THIS ATTEMPT, THE GUIDE WIRE WAS STRETCHED AND WAS UNUSABLE. THE MULTIPLE ATTEMPTS AT IMPLANTATION RESULTED IN AN EPIDURAL HEMATOMA. THERE WAS NO FURTHER INCIDENT RELATED MEDICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM IMPLANTABLE ACCESS SYSTEM LJT SMITHS MEDICAL MD (FORMERLY DELTEC, INC.) 21-1500 M56810

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention