BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL INJECTION SYSTEM

    MDR report key: 2171450 · Received June 27, 2008

    Report

    Report Number
    3007209822-2008-00001
    Event Type
    Malfunction
    Date Received
    June 27, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 23, 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 WAS DUPLICATED IN AN OVERSTRESS CONDITION. MFR'S DEVICE EVAL SUMMARY: THE COMPLAINT DEVICE WAS EVALUATED. IT WAS OBSERVED THAT A PORTION OF THE CATHETER TIP HAD BEEN SHEARED OFF AT AN ANGLE. THE INVESTIGATION RESULTED IN DUPLICATING THE FAILURE MODE USING AN OVERSTRESS BENCHTOP MODEL WITH DEVICES FROM THE SAME PRODUCTION LOT OF DEVICES. THE OVERSTRESS BENCHTOP TEST INVOLVED DELIBERATELY DEPLOYING THE CATHETER AGAINST A FIXED SURFACE TO SIMULATE DEPLOYMENT OF THE CATHETER AGAINST BONE AS WAS OBSERVED IN THE CLINICAL PROCEDURE WHERE THE FAILURE OCCURRED. THE OVERSTRESS BENCHTOP TEST MODEL MAINTAINS DEVICE BODY TEMPERATURE BY IMMERSING THE CATHETER AND NEEDLE TIP IN WATER THAT IS MAINTAINED AT BODY TEMPERATURE. THE CATHETER SHEARING IN THE PROCEDURE MOST LIKELY OCCURRED WHEN THE CATHETER WAS DEPLOYED AGAINST BONE WHICH DEFLECTED THE CATHETER FROM ITS INTENDED PATH. AS A RESULT, THE CATHETER WAS FORCED AGAINST THE HEEL OF THE NEEDLE BEVEL AND SEVERED WHEN RETRACTED INTO THE NEEDLE.

    Description of Event or Problem · 1

    THE CATHETER TIP SHEARED OFF OF THE SPINAL INJECTION SYSTEM CATHETER DURING RETRACTION OF THE CATHETER INTO THE INTRODUCER NEEDLE DURING A CERVICAL SPINE INJECTION PROCEDURE. THE PHYSICIAN COMMENTED THAT THE CATHETER WAS DEPLOYED AGAINST BONE SEVERAL TIMES WHILE ATTEMPTING TO POSITION THE CATHETER AT THE INJECTION SITE. 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. A SECOND DEVICE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE WITHOUT ISSUE. 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 101507-01

    Patients

    Seq Age Sex Outcome Treatment
    1