BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERMETIC LUMBAR CATHETER, OPEN TIP

    MDR report key: 5050573 · Received September 2, 2015

    Report

    Report Number
    2648988-2015-00065
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    August 7, 2015
    Report Date
    August 7, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K970658
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 09/23/2015. THE INVESTIGATION INCLUDED: METHOD: DHR REVIEW. REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. VISUAL INSPECTION. RESULTS: DEVICE HISTORY RECORD (DHR) OF FINISH GOOD (FG) LOT 1141897 AND 1142329 WERE REVIEWED. THE MANUFACTURING DATE FOR FINISH GOOD (FG) LOT 1141897 AND 1142329 IS 2014-05 AND 2014-06, RESPECTIVELY. THE EXPIRATION DATE FOR BOTH LOTS IS 2018-05. NO ANOMALY OR DISCREPANCIES WERE REPORTED DURING THE MANUFACTURE OF THE FG LOTS THAT COULD BE RELATED TO THE REPORTED CONDITIONS (BENT TUOHY NEEDLE TIP CAUSED CATHETER SHEARING/OBTURATOR NOT FITTING TIGHTLY). NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR FG LOT 1141897 AND 1142329 REGARDING DEFECTIVE TUOHY NEEDLES/CATHETER SHEARING OR ANY OTHER CONDITION. FAILURE ANALYSIS WAS NOT POSSIBLE SINCE COMPLAINT UNIT WAS NOT RETURNED FOR EVALUATION. HOWEVER, PICTURES WERE PROVIDED SHOWING THE REPORTED CONDITIONS. THE FOLLOWING OBSERVATIONS WERE MADE: BASED UPON PICTURE PROVIDED, IT IS EVIDENT THAT THE TIP OF THE COMPLAINT CATHETER WAS SHEARED OFF; COMPARISON BETWEEN COMPLAINT TUOHY NEEDLE AND ACCEPTABLE TUOHY NEEDLE PERFORMED AS PART OF THE INVESTIGATION SHOWED THE FOLLOWING CONDITIONS: EDGES OF THE COMPLAINT UNIT TIP ARE NOT COMPLETELY ROUNDED. THE TIP APPEARS TO BE SLIGHTLY BENT. CONCLUSION: GIVEN THAT THE TUOHY NEEDLES ARE PURCHASED FROM AN EXTERNAL SUPPLIER, A ROOT CAUSE FOR THE BENT CONDITION MAY BE RELATED TO THE SUPPLIER¿S GRINDING PROCESS. IN REGARDS TO CATHETER SHEARING, IT WAS INDICATED IN THE COMPLAINT RECORD THE FOLLOWING: ON REMOVAL OF THE CATHETER, WITH THE TUOHY AND WIRE STILL IN SITU, IT WAS FOUND THAT THE END 15MM HAD BEEN SHEARED OFF. THE TIP OF THE TUOHY WAS EXAMINED AND FOUND TO BE INTACT BUT SLIGHTLY BENT FURTHER UPWARDS, CONFIRMING WHY THE OBTURATOR DID NOT FIT TIGHTLY AGAIN AND ALSO HOW THE SILICON MUST HAVE BEEN SHEARED BY THE TIP OF THE TUOHY NEEDLE ALTHOUGH IT IS POSSIBLE THAT SOME TYPE OF DAMAGE OCCURRED TO THE CATHETER DURING INSERTION DUE TO THE TYPE OF DEFECT OBSERVED ON THE TIP OF THE TUOHY NEEDLE, A MOST LIKELY CAUSE FOR THE SHEARING MAY BE DUE TO WITHDRAWING THE CATHETER THROUGH THE TUOHY NEEDLE WHILE IT WAS STILL IN SITU SINCE THIS TYPE OF MOTION PULLS THE CATHETER AGAINST THE SHARP HEEL OF THE TUOHY NEEDLE. AS INDICATED IN THE PRODUCT¿S INSTRUCTIONS FOR USE: ¿TO AVOID POSSIBLE TRANSECTION OF THE LUMBAR CATHETER, THE CATHETER SHOULD NEVER BE WITHDRAWN THROUGH THE TUOHY NEEDLE. IF THE CATHETER NEEDS TO BE WITHDRAWN, THE TUOHY NEEDLE AND CATHETER (WITH GUIDE WIRE IF USED) MUST BE REMOVED SIMULTANEOUSLY.¿

    Description of Event or Problem · 1

    THE PRODUCT WAS USED ON A (B)(6) MALE PATIENT WITH A THORACIC AORTIC DISSECTION NEEDING A THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR), THUS THE PROPHYLACTIC USE TO MONITOR CEREBROSPINAL FLUID (CSF) DRAINAGE FOR SPINAL CORD PERFUSION PROTECTION. ON THE MORNING OF (B)(6) 2015, THE ANESTHETIST EVENTUALLY OBTAINED LOW FLOW/LOW PRESSURE CSF THROUGH THE AWAKE PATIENT'S TOUGH SKIN AND TISSUES BUT THE WHITE SILICON CATHETER WOULD NOT PASS BEYOND WHAT FELT LIKE THE TIP OF THE 14G METALLIC TUOHY NEEDLE. THEN, IT WAS REPORTED THAT IT FELT LIKE THE OBTURATOR DID NOT CLICK BACK COMPLETELY. IT WAS SUGGESTED TO USE A THIN 150 CM LONG GUIDEWIRE WHICH DID PASS THROUGH THE NEEDLE EASILY, THEN TO THREAD THE SILICON OVER IT. THE ANESTHETIST FOUND AGAIN RESISTANCE AT THE DISTANCE CORRESPONDING TO THE TUOHY TIP AND THEN RESISTANCE WHEN REMOVING IT. ON REMOVAL OF THE CATHETER, WITH THE TUOHY AND WIRE STILL IN SITU, IT WAS FOUND THAT THE END 15MM HAD BEEN SHEARED OFF, THIS DISTANCE WAS CONFIRMED WHEN A NEW CATHETER WAS COMPARED WITH IT. SURGERY DELAY OF 1 HOURS WAS REPORTED. THE NEW CATHETER WAS PLACED MUCH MORE SECURELY AFTER REPLACING THE TUOHY NEEDLE WITH A SHORT VASCULAR SHEATH. THE TIP OF THE TUOHY WAS EXAMINED AND IT WAS FOUND TO BE INTACT BUT SLIGHTLY BENT FURTHER UPWARDS, CONFIRMING WHY THE OBTURATOR DID NOT FIT TIGHTLY AGAIN AND ALSO HOW THE SILICON MUST HAVE BEEN SHEARED BY THE TIP OF THE TUOHY NEEDLE. THE NEUROSURGEONS HAVE SUGGESTED A CT SCAN. THE TEVAR PROCEDURE IN ITSELF WENT WELL. THE REST OF THE LUMBAR DRAIN APPARATUS INCLUDING MANOMETER HAS BEEN FUNCTIONING NORMALLY. THE PATIENT WOKE UP WITH NO NEUROLOGICAL DEFICIT. ADDITIONAL INFORMATION WAS OBTAINED ON 17AUG2015 WITH THE FOLLOWING: THE HOSPITAL DID NOT KEEP THE CATHETER. THE HOSPITAL HAS BEEN SCANNING THE PATIENT EVERY FEW DAYS AS PART OF USUAL MONITORING. THERE IS A PIECE OF WHAT APPEARS TO BE THE CATHETER IN PATIENT'S SPINE. THE PATIENT GOING HOME ON (B)(6) 2015. THE PATIENT IS WELL, STABLE AND NO INJURY DETECTED. WHEN THE ANESTHETIST WAS QUESTIONED REGARDING THE STATEMENT "KNOWN HAZARD WITH THIS KIT, AND HAS SEEN IT BEFORE", THE ANESTHETIST STATED THIS IS NOT NECESSARILY TO DO WITH THE INTEGRA KIT BUT FOR OTHER BRANDS AS WELL; AND THAT BECAUSE OF THE TOUHY NEEDLE BEING SO SHARP. THE NEUROSURGEON HAD STATED THAT UNLESS AN INFECTION WERE TO OCCUR, HE WOULD NOT RECOMMEND REMOVAL OF THE PIECE OF CATHETER FROM THE SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581337 HERMETIC LUMBAR CATHETER, OPEN TIP N/A JXG INTEGRA NEUROSCIENCES PR 1142329 OR 1141897

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other