BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL DURAL SEALANT SYSTEM

    MDR report key: 886228 · Received July 27, 2007

    Report

    Report Number
    3003157248-2007-00035
    Event Type
    Injury
    Date Received
    July 27, 2007
    Report Date
    February 27, 2006
    Manufacturer
    CONFLUENT SURGICAL
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CSF LEAK WITH PSEUDOMENINGOCELE WAS REPORTED FOLLOWING A CRANIAL PROCEDURE IN WHICH DURASEAL WAS USED. A RE-OPERATION WAS DONE 5 1/2 WEEKS AFTER INITIAL SURGERY TO REPAIR THE CSF LEAK. THE DISTRIBUTOR REPRESENTATIVE DISCUSSED WITH THE INCIDENT WITH THE SURGEON AND CONFIRMED THAT THE LEAK WAS LOCATED ALONG THE BONY EDGE OF THE CRANIOTOMY. NO LEAK WAS FOUND ALONG THE SUTURE LINE WHERE DURASEAL HAD BEEN APPLIED. FOLLOWING RE-OPERATION, PATIENT RECOVERED WITHOUT FURTHER INCIDENT. AS DESCRIBED IN THE DURASEAL INSTRUCTIONS FOR USE (IFU): "THE DURASEAL DURAL SEALANT SYSTEM IS INTENDED FOR USE AS AN ADJUNCT TO SUTURED DURAL REPAIR DURING CRANIAL SURGERY TO PROVIDE WATERTIGHT CLOSURE". THE IFU FURTHER CITES THE INCIDENCE OF CSF LEAKS IN THE CLINICAL STUDY: "THE INCIDENCE OF POST-OP CSF LEAKS IN THIS STUDY WAS 4.5%. OF THESE 1.8% WERE INCISIONAL AND 2.7% WERE PSEUDOMENINGOCELES".

    Description of Event or Problem · 1

    DISTRIBUTOR REPRESENTATIVE REPORTED A CEREBROSPINAL FLUID (CSF) LEAK AFTER A CHIARI MALFORMATION DECOMPRESSION PROCEDURE. DURAGUARD (SYNOVIS SURGICAL INNOVATIONS) AND DURASEAL WERE USED IN THIS PROCEDURE. PATIENT WAS READMITTED 5 1/2 WEEKS AFTER INITIAL SURGERY, WHERE AN MRI CONFIRMED A CSF LEAK WITH A PSEUDOMENINGOCELE. FOLLOWING REOPERATION, PATIENT RECOVERED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASEAL DURAL SEALANT SYSTEM SURGICAL SEALANT, POLYMERIZING NQR CONFLUENT SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention