BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VENT. BOLT 110-4HMT

    MDR report key: 1190802 · Received September 24, 2008

    Report

    Report Number
    2023988-2008-00034
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 18, 2008
    Report Date
    September 24, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    GWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE CATHETER BROKE OFF IN THE PT'S HEAD. THE DOCTOR REMOVED THE ITEM WITH HEMOSTATS. THE PT HAD A CT SCAN TO ENSURE THERE WAS NO FOREIGN BODY LEFT IN THE PT. NO FOREIGN BODY WAS SEEN ON IMAGING. INTEGRA MADE A REQUEST IN WRITING FOR ADDITIONAL INFO. IN RESPONSE, IN A FOLLOW UP TELEPHONE CALL TO INTEGRA, THE HOSPITAL RISK MANAGER STATED THAT THE PT HAD BEEN ADMITTED WITH AN ACUTE HEMORRHAGIC STROKE. SHE HAD MASSIVE BRAIN STEM INFARCTION AND THE PROGNOSIS WAS "HOPELESS" FROM THE TIME OF THE STROKE. DURING THE PROCEDURE TO REMOVE THE CATHETER, THE PHYSICIAN PULLED ON IT; PART OF THE CATHETER BROKE AND THE DISTAL PORTION WAS RETAINED IN THE PATIENT AND WAS REMOVED DURING THE PROCEDURE USING A HEMOSTAT. THE PT THEN HAD A CT SCAN. NO FOREIGN BODY WAS SEEN ON IMAGING AND IT IS REPORTED THAT NO FOREIGN BODY REMAINED IN THE PT. THE PT IS DECEASED. THE DATE OF DEATH WAS NOT KNOWN BY THE REPORTER. THE REPORTER STATED THAT THE CAUSE OF DEATH WAS NOT RELATED TO USE OF THE DEVICE, OR THE BREAKAGE, OR REMOVAL OF THE DEVICE. THE LOT NUMBER OF THE DEVICE WAS NOT RECORDED IN THE PT'S NOTES AND IS NOT KNOWN. THE DEVICE WILL NOT BE RELEASED FOR EVALUATION BY THE HOSPITAL ON INSTRUCTIONS OF AN ATTORNEY. PHOTOGRAPHS OF THE DEVICE ARE AVAILABLE AND WILL BE EMAILED TO INTEGRA FOR EVALUATION. THE DEVICE HAD FUNCTIONED SATISFACTORILY PRIOR TO REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO VENT. BOLT 110-4HMT PRESSURE MONITORING CATHETER KIT GWM INTEGRA NEUROSCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention