BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NBCA LIQUID EMBOLIC SYSTEM 2

    MDR report key: 2840124 · Received November 20, 2012

    Report

    Report Number
    1058196-2012-00420
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    September 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KGG
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS (B)(6) MALE WAS TREATED WITH ONE KIT OF TRUFILL NBCA LIQUID EMBOLIC SYSTEM ((B)(4)/LOT UNKNOWN) FOR AN ARTERIOVENOUS MALFORMATION (AVM). THE PATIENT HAD A FEVER AND RASH LIKE SYMPTOMS THAT THE PHYSICIAN SUSPECTED MAY BE AN ALLERGY TO NBCA (EITHER CYANOACRYLATE OR ETHIODIZED OIL). THE PATIENT WAS DISCHARGED TWO DAYS POST PROCEDURE WITH A SMALL RASH ON HIS FEET AND THEN WAS RE-ADMITTED THE FOLLOWING DAY WITH A FEVER. THE PATIENT WAS THEN REFERRED TO AN ALLERGIST FOR EVALUATION AND A TRUFILL KIT FOR EVALUATION ((B)(4)/LOT 268818) WAS SUPPLIED FOR EVALUATION UNDER SUPERVISION OF A PHYSICIAN. ADDITIONAL FOLLOW-UP INFORMATION REPORTED THAT THE RESULTS OF THE ALLERGY TESTING FOUND THAT HE WAS NOT ALLERGIC TO NBCA; THEY ARE NOT SURE WHAT CAUSED THE ALLERGIC REACTION. THE PATIENT HAS SINCE HAD FOLLOW-UP TREATMENT USING NBCA TO OBLITERATE THE LAST OF THE AVM. ONE MONTH AFTER THIS FOLLOW-UP TREATMENT THERE HAS BEEN NO SIGN OF ALLERGIC REACTION. THE NBCA REMAINS IMPLANTED AND THE LOT NUMBER IS NOT AVAILABLE; THEREFORE, THE DEVICE HISTORY RECORDS REVIEW CANNOT BE COMPLETED. THE INSTRUCTIONS FOR USE OUTLINES THAT ALLERGIC REACTION IS AN ADVERSE EVENT WHICH MAY BE ASSOCIATED WITH EMBOLIZATION PROCEDURES (INCLUDING THOSE OBSERVED DURING THE (B)(4) STUDY) AND MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. THE FOLLOW-UP INFORMATION REPORTED NEGATIVE ALLERGY TESTING WITH AN NBCA TEST KIT AND FOLLOW-UP TREATMENT WITH NBCA WITHOUT ANY REACTION. ADDITIONALLY BASED ON THIS, IT WAS REPORTED THAT IT WAS DETERMINED THAT ALTHOUGH THE CAUSE OF THE REPORTED SUSPECTED ALLERGIC REACTION IS NOT KNOWN, IT WAS NOT RELATED TO THE NBCA. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    PEDIATRIC PATIENT TREATED AND DISCHARGED WITH A SMALL RASH ON HIS FEET. THE PATIENT DEVELOPED A FEVER AND WAS RE-ADMITTED TO THE HOSPITAL. PATIENT WAS REFERRED TO ALLERGIST UPON REQUEST FROM HIS MOTHER. REP RECEIVED PHONE CALL TO ALERT OF THE INCIDENT ON AND REQUESTED A SAMPLE KIT FOR EVALUATION. EVALUATION KIT FOR ALLERGIST, UNDER SUPERVISION OF PHYSICIAN SENT TO HOSPITAL VIA REPRESENTATIVE. (B)(4), LOT 268818. NO DATE ESTABLISHED YET FOR TEST. UPDATE WILL BE PROVIDED AS SOON AS THEY ARE AVAILABLE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS TREATED WITH ONE KIT OF NBCA GLUE FOR AVM. PATIENT HAD A FEVER AND RASH LIKE SYMPTOMS THAT THE PHYSICIAN SUSPECTED MAY BE AN ALLERGY TO NBCA (EITHER CYANOACRYLATE OR ETHIODIZED OIL). PHYSICIAN HAS NOT CONCLUSIVELY PROVEN THIS AT THIS TIME. THE PRODUCT DID NOT EXPIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NBCA LIQUID EMBOLIC SYSTEM 2 CNV_NBCA (MFE) KGG CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR