BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERMETIC LUMBAR CATHETER, OPEN TIP

    MDR report key: 5183191 · Received October 28, 2015

    Report

    Report Number
    2648988-2015-00073
    Event Type
    Injury
    Date Received
    October 28, 2015
    Report Date
    October 6, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K972994
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 11/05/2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: BASED ON THE PICTURES INCLUDED AS PART OF THE COMPLAINT RECORD, THE FOLLOWING OBSERVATIONS WERE MADE: THE TIP OF THE COMPLAINT CATHETER WAS SHEARED OFF. THE CATHETER TIP WAS RETAINED IN PATIENT. THE CATHETER WAS VISUALLY INSPECTED AND THE FOLLOWING OBSERVATIONS WERE NOTICED AT THE TIP OF THE CATHETER: THE TIP OF THE CATHETER WAS SHEARED OFF. THE TRANSVERSE CUT WAS OBSERVED TO BE CLEAN AND PRECISE RESEMBLING THAT MADE WITH A SHARP SURGICAL INSTRUMENT. DEVICE HISTORY RECORD (DHR) OF FINISH GOOD (FG) LOT 1151775 WAS REVIEWED IN ORDER TO DETECT ANY ANOMALIES THAT COULD HAVE OCCURRED DURING THE MANUFACTURING PROCESS OF THE PRODUCT WHICH COULD HAVE CONTRIBUTED AND/OR BE RELATED WITH THE REPORTED CONDITION BEING INVESTIGATED (BROKEN CATHETER TIP). THE MANUFACTURING DATE AND EXPIRATION DATE FOR FINISH GOOD (FG) LOT 1151775 IS 2015-05 AND 2020-06, RESPECTIVELY. A REVIEW OF INTEGRA'S COMPLAINT SYSTEM; APPROXIMATELY (B)(4) UNITS OF EXTERNAL LUMBAR DRAINAGE CATHETERS HAVE BEEN SHIPPED FOR DISTRIBUTION FROM 2013 TO OCTOBER 22, 2015, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). CONCLUSION: BASED ON THE DESCRIPTION OF THE EVENT AND PRODUCT FAILURE ANALYSIS, THE REPORTED CONDITION 'BROKEN CATHETER TIP' WAS CONFIRMED. NO ASSIGNABLE CAUSES THAT COULD BE ASSOCIATED TO THE MANUFACTURING PROCESS WERE DETERMINED BASED ON THE REVIEW OF PRODUCT DEVICE HISTORY RECORD (DHR), CAPA, NCR, AND SCAR HISTORY. AS INDICATED IN THE COMPLAINT RECORD: ACCORDING TO THE SURGEON, CATHETER INSERTION DID NOT GO SMOOTHLY WHILE TRYING TO INSERT THE CATHETER THROUGH THE GUIDE CANNULA, SO HE TRIED TO PULL OUT THE CATHETER. HE DID NOT FEEL ANY RESISTANCE NOR APPLIED UNUSUAL FORCE, BUT THE CATHETER WAS BROKEN AND ABOUT 2.5CM OF THE CATHETER TIP WAS LEFT IN THE PATIENT. ALTHOUGH NO FURTHER DETAILS WERE PROVIDED IN THE COMPLAINT RECORD INDICATING HOW THE CATHETER WAS RETRIEVED, THE INFORMATION INITIALLY PROVIDED SUGGESTS THAT THE CATHETER WAS WITHDRAWN THROUGH THE TUOHY NEEDLE WHILE IT WAS 'IN-SITU.' ADDITIONALLY, THE TRANSVERSE CUT OBSERVED AT THE TIP OF THE CATHETER WHICH RESEMBLES THAT MADE WITH A SHARP SURGICAL INSTRUMENT, FURTHER REINFORCES THE ASSUMPTION THAT THE CATHETER WAS WITHDRAWN THROUGH THE TUOHY NEEDLE WHILE IT WAS 'IN-SITU.' IT IS INDICATED IN THE PRODUCT'S INSTRUCTIONS FOR USE THAT, "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

    IN AN ATTEMPT TO REMOVE THE CATHETER, IT WAS BROKEN AND APPROXIMATELY 2.5CM OF THE CATHETER WAS LEFT IN THE PATIENT'S BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716622 HERMETIC LUMBAR CATHETER, OPEN TIP N/A JXG INTEGRA NEUROSCIENCES PR 1151775

    Patients

    Seq Age Sex Outcome Treatment
    1 Other