BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BACTISEAL EVD CATHETER

    MDR report key: 17977504 · Received October 20, 2023

    Report

    Report Number
    3013886523-2023-00367
    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
    K102589
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVD CATHETER (ID 821745) 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. HOWEVER, THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE. 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.

    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

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2023-00366 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
    1996449 CODMAN BACTISEAL EVD CATHETER BACTISEAL EVD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 6793214

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female