BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERMETIC LUMBAR CATHETER, CLOSED TIP

    MDR report key: 8220500 · Received January 5, 2019

    Report

    Report Number
    2648988-2018-00057
    Event Type
    Injury
    Date Received
    January 5, 2019
    Report Date
    December 14, 2018
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K970658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT UNIT WILL BE RETURNED AND THUS NO FAILURE ANALYSIS IS POSSIBLE SINCE IT CORRESPONDS TO A STUDY PUBLISHED IN 2007 THAT PERFORMED A RETROSPECTIVE EVALUATION FROM JUNE 2003 TO AUGUST 2005. IT IS NOT POSSIBLE TO PERFORM THE DHR REVIEW AND NEITHER TO IDENTIFY THE MANUFACTURING TIME FRAME FOR THE EVENT/NC, SCAR, AND CAPA HISTORIES REVIEW. THUS, THE REPORTED CONDITION IS UNCONFIRMED. BASED ON THE LACK OF INFORMATION, THE ROOT CAUSE IS UNDETERMINED. LINKED TO MFG REPORT NUMBER: 2648988-2018-00058. DOI: 10.1007/S12028-007-0047-3.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS. NEUROCRITICAL CARE (2007) PUBLISHED: "LUMBAR DRAINAGE FOR SUBARACHNOID HEMORRHAGE: TECHNICAL CONSIDERATIONS AND SAFETY ANALYSIS". RECENT AND ON GOING CLINICAL RESEARCH TRIALS MAY INDICATE THAT THE INCIDENCE OF VASOSPASM IS LESS IN PATIENTS TREATED WITH LUMBAR DRAINS(LD) FOLLOWING SUBARACHNOID HEMORRHAGE (SAH) THAN WITH PATIENTS TREATED WITH EXTERNAL VENTRICULAR DRAINAGE (EVD) ALONE. THESE STUDIES HAVE SPARKED INTEREST IN THE MORE AGGRESSIVE USE OF LDS IN PATIENTS WITH ANEURYSMAL SAH BUT SOME CLINICIANS HAVE BEEN CONCERNED ABOUT SAFETY. METHODS: A RETROSPECTIVE REVIEW OF 140 PATIENTS WITH ANEURYSMAL SAH TREATED IN A NEURO-CRITICAL CARE UNIT WAS UNDERTAKEN FROM JUNE 2003 TO AUGUST 2005. IN MOST CASES AN EVD WAS PLACED INITIALLY FOR MANAGEMENT OF ACUTE HYDROCEPHALUS. IN A COHORT OF 25 PATIENTS, HOWEVER, A LUMBAR DRAIN WAS SUBSEQUENTLY USED. THE PATIENT AGES RANGED FROM 19 TO 84, WITH A MEAN AGE OF 51. THE SEX DISTRIBUTION DEMONSTRATED THAT 44% WERE MALE AND 56% WERE FEMALE. THE LD WAS PLACED USING AN INTEGRA HERMETIC LUMBAR CATHETER KIT (WHICH INCLUDES A 14 GAUGE 9 CM TUOHY SPINAL NEEDLE AND AN 80 CM X 7 MM ID AND 1.5 MM OD HERMETIC CLOSED TIP LUMBAR CATHETER). PLACEMENT WAS DONE IN EITHER THE SITTING POSITION OR THE LATERAL DECUBITUS POSITION AT THE BEDSIDE IN THE NEURO-CRITICAL CARE UNIT . TYPICALLY THE L3-4 INTER-SPACE WAS SELECTED ALTHOUGH OCCASIONALLY THE SPACE ABOVE OR BELOW WAS USED AS THE SITE OF INSERTION. THE DRAINAGE LEVEL FOR THE COLLECTION CHAMBER WAS USUALLY SET AT THE LEVEL OF THE SHOULDER. NURSING STAFF WAS INSTRUCTED TO WATCH THE AMOUNT OF DRAINAGE AND THE CLINICAL STATUS OF THE PATIENT. IF THERE WAS MORE THAN 20 CC OF CSF DRAINED OVER AN ONE HOUR PERIOD, THE LD LEVEL WAS USUALLY RAISED 5¿10 CM AND, DEPENDING ON THE SPEED OF THE DRAINAGE, TEMPORARILY CLOSED. THE NURSING STAFF WAS INSTRUCTED TO BE ESPECIALLY VIGILANT FOR DETERIORATION IN LEVEL OF CONSCIOUSNESS AND PUPILLARY CHANGES, AND TO CLAMP THE LD AND CALL A PHYSICIAN IF ABNORMALITIES WERE NOTED. IF THE PATIENT ALREADY HAD AN EVD IN PLACE AT THE TIME OF LD INSERTION, THE INTRACRANIAL PRESSURE (ICP) WAS MONITORED. THE EVD WAS THEN GRADUALLY RAISED AND CLAMPED OVER 24¿48 HOURS AS CSF DRAINAGE WAS SHIFTED ENTIRELY TO THE LD. WHEN THE CSF WAS NO LONGER RED-TINGED AND SIMPLY XANTHOCHROMIC, THE LD WAS CLAMPED. IF THE PATIENT TOLERATED THIS CLINICALLY FOR ONE DAY, THEN THE LD WAS REMOVED. OTHERWISE A VENTRICULO-PERITONEAL SHUNT WAS PLACED. RESULTS: OUT OF A TOTAL OF 140 PATIENTS WITH ACUTE ANEURYSMAL SAH, 126 REQUIRED CSF DRAINAGE. OF THESE, 25 HAD LDS INSERTED. ONE PATIENT WHO HAD ACQUIRED A CNS INFECTION AS A COMPLICATION OF AN EVD HAD A LUMBAR DRAIN USED DURING THE PHASE OF ANTIBIOTIC TREATMENT WITH NO UNTOWARD EFFECTS. ONE PATIENT WITH A LD HAD THE DRAIN BREAK BETWEEN THE PATIENT AND THE COLLECTION DEVICE. THE CATHETER WAS REPAIRED AT THE BEDSIDE WITH NO COMPLICATIONS. THERE WERE NO CATHETERS THAT BROKE LEAVING RETAINED CATHETER FRAGMENTS IN THE PATIENT¿S BODY. ONE PATIENT EXHIBITED PUPILLARY CHANGES AFTER INSTITUTION OF LUMBAR CSF DRAINAGE. HE HAD A RELATIVELY ¿¿TIGHT¿¿ BRAIN, WITH BILATERAL ANTERIOR CEREBRAL ARTERY INFARCTIONS FROM VASOSPASM, AND AN ATTEMPT AT LUMBAR DRAINAGE WAS MADE BECAUSE OF CONCERNS OVER THE POTENTIAL OF AN EVD INFECTION. HE HAD REQUIRED PROLONGED CSF DRAINAGE WITH AN EVD APPROACHING THREE WEEKS. HIS NEUROLOGICAL EXAM PRIOR TO USE OF THE LD DEMONSTRATED BILATERAL FLEXION IN THE UPPER EXTREMITIES IN RESPONSE TO PAIN AND PUPILS OF 3 MM EACH BOTH REACTIVE. SEVERAL HOURS AFTER LUMBAR DRAINAGE WAS INSTITUTED HE DEVELOPED EXTENSOR POSTURING ON THE RIGHT AS WELL AS A 5 MM AND FIXED AND LATER REMOVED. WITHIN EIGHT HOURS HIS NEUROLOGICAL EXAM RETURNED TO BASELINE WITH BILATERAL DECORTICATE POSTURING AND PUPILS OF 3 MM EACH WITH BOTH BEING REACTIVE. A NEW EVD WAS PLACED. HE SUFFERED NO ADDITIONAL CHRONIC NEUROLOGICAL DEFICIT FROM THIS INCIDENT. OF THE 25 PATIENTS TREATED WITH A LUMBAR DRAIN THREE (12%) DIED. HOWEVER THEIR DEATHS WERE NOT RELATED TO THE LUMBAR DRAINS BUT RATHER TO OTHER PROBLEMS. OF THE 25 PATIENTS TREATED WITH A LUMBAR DRAIN 10 (40%) WERE DISCHARGED TO HOME AND 12 (48%) WERE DISCHARGED TO REHABILITATION FACILITIES. SEVERAL PATIENTS HAD MULTIPLE ANEURYSMS. ALL PATIENTS RECEIVED PROPHYLACTIC NIMODIPINE AND TRIPLE H THERAPY FOR VASOSPASM. THOSE WITH MORE SEVERE VASOSPASM WERE EVALUATED WITH CEREBRAL ANGIOGRAPHY AND RECEIVED ANGIOPLASTY OR INTERARTERIAL VERAPAMIL. IN THIS SERIES OF 25 PATIENTS, 27 ANEURYSMS WERE TREATED, 21 (78%) WITH ENDOVASCULAR COILING, AND 6 (22%) WITH A CRANIOTOMY AND CLIPPING. LUMBAR DRAINS WERE LEFT IN PLACE FROM 2 TO 18 DAYS WITH A MEAN OF 6.5 DAYS. CONCLUSIONS: LDS ARE SAFE WHEN USED IN THE SETTING OF ANEURYSMAL SAH IF APPROPRIATE PATIENT SELECTION AND GOOD TECHNIQUE ARE EMPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13216 HERMETIC LUMBAR CATHETER, CLOSED TIP N/A JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1