BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL INJECTION SYSTEM

    MDR report key: 2171451 · Received September 4, 2008

    Report

    Report Number
    3007209822-2008-00002
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    August 5, 2008
    Report Date
    September 4, 2008
    Manufacturer
    LAURIMED LLC
    Product Code
    BSP
    PMA / PMN Number
    K080140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: DEVICE EVALUATED AND FAILURE COULD NOT BE DUPLICATED. MFR'S DEVICE EVAL SUMMARY: THE COMPLAINT DEVICE WAS EVALUATED. IT WAS OBSERVED THAT A PORTION OF THE CATHETER TIP HAD BEEN BROKEN OFF PERPENDICULAR TO THE AXIS OF THE CATHETER. FLUOROSCOPIC IMAGES FROM THE CASE WERE REVIEWED AND IT WAS OBSERVED THAT THE CATHETER TIP BECAME DETACHED AFTER THE DEVICE WAS ADVANCED THROUGH TISSUE WITH THE CATHETER RESIDING OUTSIDE OF THE NEEDLE. DEVICES FROM THE SAME PRODUCTION LOT AS THE COMPLAINT DEVICE WERE TESTED. THE DEVICES WERE ADVANCED, WITH THE CATHETERS POSITIONED OUTSIDE OF THE NEEDLE, THROUGH A VARIETY OF MATERIALS, INCLUDING SILICONE RUBBER, AND MECHANICAL LOADING CONDITIONS IN ORDER TO SIMULATE ADVANCEMENT IN AN OVERSTRESS TISSUE MODEL. THE INVESTIGATION DID NOT RESULT IN DUPLICATING THE MODE OF FAILURE IN THE RETURNED DEVICE.

    Description of Event or Problem · 1

    THE CATHETER TIP BROKE OFF OF THE SPINAL INJECTION SYSTEM CATHETER DURING A CERVICAL SPINE INJECTION PROCEDURE. THE CATHETER TIP FRAGMENT REMAINED IN THE PT'S SOFT TISSUE/MUSCLE APPROX 1 CM LATERAL TO AND OUTSIDE OF THE SPINE AS SEEN USING FLUOROSCOPY BY THE PHYSICIAN. THE PHYSICIAN DETERMINED THE FRAGMENT IS NOT IN A POSITION THAT MAY CAUSE SEQUELAE AND DID NOT ATTEMPT TO REMOVE IT. THE PROCEDURE WAS COMPLETED USING A STANDARD NEEDLE. THE PT WAS INFORMED OF THE FRAGMENT. THERE WERE NO REPORTED PT NEUROLOGICAL ISSUES OR ADVERSE CLINICAL SEQUELA REPORTED DURING OR AFTER THE PROCEDURE. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL INJECTION SYSTEM CONDUCTION NEEDLE W/WO INTRODUCER BSP LAURIMED LLC FG-000001 LMD-113007-03

    Patients

    Seq Age Sex Outcome Treatment
    1