BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDS DRAINAGE SYS NO V CATH

    MDR report key: 17977574 · Received October 20, 2023

    Report

    Report Number
    3013886523-2023-00366
    Event Type
    Injury
    Date Received
    October 20, 2023
    Date of Event
    June 30, 2023
    Report Date
    January 5, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EDS DRAINAGE SYSTEM (ID 821731C) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. HOSPITAL CONFIRMED TO MEDICAL DIRECTOR THAT EVD WAS PROBABLY NOT THE CAUSE OF THE ISSUE BUT HOSPITAL FOLLOW HIS POLICY AND REMOVE BOTH. THE COMPLAINT IS BASED ON A CATHETER 821745 (MFG REPORT NUMBER 3013886523-2023-00367.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2023-00367. CLINICAL STUDY: "THE SITE HAS REFERENCED THE SYSTEM AS THE EDS3 SYSTEM THAT COMES WITHOUT THE VENTRICULAR CATHETER. THE SITE INDICATED THAT THEY DID FLUSH THE CATHETER, BUT THAT OCCLUSION PERSISTED SO THEY REMOVED THE ENTIRE SYSTEM. AFTER QUERY PERTAINING TO THE CATHETER USED, A RECENT ENTRY WAS ADDED TO THE DATABASE THAT INCLUDED THE 82-1745 CODMAN BACTISEAL EVD CATHETER SET. BASED ON THE PRESENTING PATHOLOGY I.E., ¿SUBARACHNOID HEMORRHAGE WITH VENTRICULAR BREAKTHROUGH, PRESUMABLY BASED ON PICA ANEURYSM LEFT¿ AND THE USE OF BACTISEAL 82-1745 THAT INCLUDES THE SMALLEST LUMEN, (1.5 MM ID) OCCLUSION OF THE CATHETER IS LIKELY. ADVERSE EFFECTS INCLUDED IN THE BACTISEAL IFU OF THE CATHETER INCLUDE OCCLUSION DUE TO ¿PARTICULATE MATTER SUCH AS BLOOD CLOTS¿ AND THEREFOR MAY NOT INDICATE DEVICE RELATIONSHIP TO THE EVENT. MANAGEMENT OF EVD IN SAH, IF AN INTERMITTENT DRAINAGE MAY FURTHER BURDEN THE PATIENT WITH AN INCREASED RISK OF COMPLICATIONS (E.G., CLOGGED CATHETER, HEMORRHAGE, AND NEED FOR REPLACEMENT)." WHAT IS EXACTLY THE ISSUE WITH THE DEVICE? ¿OBSTRUCTION OF THE EVD SYSTEM?¿ WHAT WAS THE CONSEQUENCE FOR THE PATIENT? "HEADACHE?" THE STUDY SITE DID IN FACT MAKE THE CHANGES FROM THE EVD TO THE CATHETER AND HAS LISTED. THE RELATIONSHIP TO CAUSAL FOR THE DEVICE OCCLUSION EXTERNAL DRAINAGE IMPLANTED ON (B)(6) 2023, DATE OF THE ADVERSE EVENT (B)(6) 2023, ON CT-SCAN ON (B)(6) 2023: RESULTS: INCREASE EDEMA AND APPEARANCE OF A SMALL HEMORRHAGE ON THE COURSE OF THE DRAIN. EVD WAS REMOVED ON (B)(6) 2023 CAUSAL RELATIONSHIP TO DEVICE OUTCOME : RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104396 EDS DRAINAGE SYS NO V CATH CSF DRAIN SYS/CRANIAL ACCESS JXG INTEGRA LIFESCIENCES MANSFIELD 7033999

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female