BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERMETIC LUMBAR CATHETER CLOSED TIP

    MDR report key: 1802964 · Received August 12, 2010

    Report

    Report Number
    MW5017086
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    May 7, 2010
    Report Date
    August 12, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS GENTLEMAN PRESENTED FOR REPAIR OF A THORACIC AORTIC ANEURYSM WITH AN ENDOLUMINAL STENT GRAFT. THE PERIOPERATIVE PLAN WAS FOR A LUMBAR CSF DRAIN PLACEMENT. AFTER STERILE PREPARATION WITH CHLORHEXIDINE WITH THE PT IN THE SITTING POSITION, THE TUOHY THAT IS PROVIDED IN THE LUMBAR SPINAL DRAIN KIT -HERMETICZ LUMBAR CATHETER CLOSED TIP (B)(4) WAS INTRODUCED INTO THE L4-L5 INTERSPACE AFTER LOCAL ANESTHESIA WITH 2% LIDOCAINE. THE LEVEL WAS IDENTIFIED BY PALPATION OF HIS SPINE/LANDMARKS. CSF WAS IMMEDIATELY OBTAINED. LOST OF RESISTANCE TO SALINE/AIR WAS NOT DONE, THEREFORE THE EPIDURAL SPACE WAS NOT IDENTIFIED. THE CATHETER WAS INSERTED WITH GUIDEWIRE IN PLACE. PRIOR TO PROCEDURE COMMENCEMENT, CATHETER WAS FIPREPPEDFL IN TYPICAL FASHION WITH STERILE SALINE. THE CATHETER WAS INSERTED VIA THE TUOHY BUT IT WOULD NOT THREAD BEYOND THE NEEDLE TIP. THE CATHETER AND THE TUOHY WAS REMOVED AS A SINGLE UNIT AND THE ABOVE PROCEDURE WAS ATTEMPTED ONE LEVEL HIGHER USING THE SAME TECHNIQUE AS STATED ABOVE. AGAIN, IMMEDIATE CSF WAS OBTAINED AND THE CATHETER/GUIDEWIRE THREADED EASILY TO 7 CM BEYOND THE NEEDLE TIP WITH ANTICIPATION THAT SOME OF THE CATHETER MAY BE PULLED OUT WHEN THE NEEDLE WAS REMOVED LEAVING ABOUT 5 CM IN THE INTRATHECAL SPACE. HOWEVER, WHEN THE GUIDEWIRE WAS REMOVED, THERE WAS NO CSF FLOW THROUGH THE CATHETER. A 3 ML SYRINGE WAS ATTACHED TO THE END OF THE CATHETER AND THERE WAS STILL NO CSF FLOW WITH ASPIRATION. THE CATHETER WAS THEN PULLED BACK SLOWLY WHILE ASPIRATION OF THE SYRINGE WAS APPLIED. AFTER A COUPLE OF CM OF CATHETER WAS PULLED BACK THERE WAS STILL NO CSF FLOW AND IT WAS DIFFICULT TO PULL THE CATHETER BACK. WE DECIDED TO REMOVE THE CATHETER AND GENTLE TRACTION WITH HANDS CLOSE TO THE PT'S BACK WAS APPLIED TO THE CATHETER WITH THE PT IN THE EXACT SAME POSITION THAT HE WAS IN WHEN THE CATHETER THREADED. IT WAS APPARENT THAT THERE WAS SOME STRETCHING THAT WAS TAKING PLACE OF THE CATHETER AND IT WAS NOT FIFREEINGFL ITSELF. THE NEXT THING THAT HAPPENED WAS THAT IT SNAPPED AND THERE WAS NO END OF IT THAT WAS ABLE TO BE SEEN AT THE SKIN SITE. THE LUMBAR DRAIN CATHETER HAD SHEARED IN TWO PARTS AND AN ESTIMATED 9CM PIECE WAS UNRETRIEVABLE AND LEFT IN THE PT. DATE OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: THORACIC AORTIC ANEURYSM REPAIR- CSF DRAINAGE. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERMETIC LUMBAR CATHETER CLOSED TIP LUMBAR DRAIN CATHETER JXG INTEGRA NEUROSCIENCES INS-5010

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other