BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BACTISEAL EVD CATHETER

    MDR report key: 20578472 · Received October 31, 2024

    Report

    Report Number
    3013886523-2024-00331
    Event Type
    Injury
    Date Received
    October 31, 2024
    Report Date
    January 9, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780515593
    PMA / PMN Number
    K102589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED. CSF CULTURES: SEPT 15 - NEG, (B)(6) - NEG, (B)(6)- NEG, (B)(6) - NEG - (B)(6): GRAM STAIN PRELIMINARY - MANY POLYMORPHONUCLEAR CELLS / NO ORGANISMS SEEN - PRIMARY CULTURE: NO GROWTH AFTER 72 HOURS / BROTH CULTURE ONLY: STAPHYLOCOCCUS EPIDERMIDIS - (B)(6): GRAM STAIN PRELIMINARY - POLYMORPHONUCLEAR CELLS PRESENT / RARE SQUAMOUS EPITHELIAL CELLS / RARE GRAM POSITIVE COCCI - CULTURE - CSF PRELIMINARY - SCANT GROWTH OF STAPHYLOCOCCUS EPIDERMIDIS - EVD SYSTEM (NOT CATHETER) CHANGED - (B)(6): GRAM STAIN PRELIMINARY - POLYMORPHONUCLEAR CELLS PRESENT / NO ORGANISMS SEEN PRELIMINARY - CULTURE - CSF PRELIMINARY - SCANT GROWTH OF STAPHYLOCOCCUS EPIDERMIDIS. NO CELL COUNT WAS DONE. - PT WAS NOT SYMPTOMATIC OF A CSF INFECTION AT THIS TIME - IS INFECTION DEVICE RELATED? IF NOT, IS IT KNOWN WHAT CAUSED IT? "YES" - DID ANYTHING HAPPEN DURING THE RECENT PROCEDURE THAT MAY HAVE CAUSED OR ATTRIBUTED TO INFECTION? "LUNG INFECTION AND? (B)(6)" - WAS THE PATIENT PLACED ON ANTIBIOTICS? "YES" - WHAT TREATMENT AND OR MEDICATION WAS GIVEN FOR THE INFECTION? IF MEDICATIONS WERE ADMINISTERED, PLEASE INCLUDE MEDICATION NAMES: "EVD REPLACED AND CHANGED SITE. ANTIBIOTICS ¿ VANCOMYCIN, CEFTRIAXONE, MEROPENUM, ANCEF, FLAGYL, PIPTAZ (NOT ALL AT ONCE)" - PROVIDE NEXT COURSE OF ACTION, IF ANY: "THE EVD WAS REMOVED AND REPLACED." - WHAT IS THE HEALTH HISTORY OF THE PATIENT? "DIAGNOSED WITH 4TH VENTRICULAR TUMOR" - PATIENT OUTCOME OR CURRENT STATUS WITH REGARDS TO THE INFECTION. CSF INFECTION CLEARED ¿ "VP SHUNT INSERTED. EVENTUALLY BECAME SYMPTOMATIC AND DIAGNOSED WITH ANOTHER CSF INFECTION (STAPH EPIDERMIDIS) ¿ VP SHUNT REMOVED, EVD INSERTED AND ON ANTIBIOTICS" - PLEASE CONFIRM IF EDS3 SYSTEM IS AN INTEGRA PRODUCT. IF YES, PLEASE PROVIDE PRODUCT INFORMATION: "YES, THIS IS AN INTEGRA PRODUCT. SKU (B)(4). LOT: NOT AVAILABLE"

    Additional Manufacturer Narrative · 0

    THE EVD BACTISEAL CATHETER (ID 821745) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-1745 WITH LOT 7328489, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. ALL FINISHED GOODS TEST RESULTS, INCLUDING ENDOTOXIN SATISFACTORILY MET THE REQUIREMENTS. FAILURE ANALYSIS - THE CATHETER WAS VISUALLY INSPECTED; NO DEFECT WAS NOTED. THE CATHETER WAS IRRIGATED, NO OCCLUSION NOTED. THE CATHETER WAS LEAK TESTED NO LEAK NOTED. ROOT CAUSE ANALYSIS - THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE LINKED TO THE PATIENT AND HOSPITAL SURROUNDINGS AND AS MENTIONED IN THE IFU: THE QUANTITIES OF RIFAMPIN AND CLINDAMYCIN HYDROCHLORIDE USED TO IMPREGNATE THE BACTISEAL EVD CATHETER ARE ONLY A FRACTION OF A THERAPEUTIC DOSE OF THESE TWO ANTIBIOTICS AND HAVE NO POTENTIAL FOR ANY SYSTEMIC THERAPEUTIC EFFECT.

    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

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED AN EVD BACTISEAL CATHETER (ID 821745) WAS INSERTED ON (B)(6).2024. THE PATIENT HAD A POSITIVE CSF CULTURE FOR STAPHYLOCOCCUS EPIDERMIDIS AFTER THE EVD WAS INSERTED. A ROUTINE CULTURE WAS TAKEN FROM THE SAMPLE PORT NEAR THE COLLECTION CHAMBER, NO SIGNS OF CSF INFECTION WERE PRESENT. IN OCTOBER 5, A GRAM STAIN PRELIMINARY SHOWED: MANY POLYMORPHONUCLEAR CELLS / NO ORGANISMS SEEN PRIMARY CULTURE: NO GROWTH AFTER 72 HOURS / BROTH CULTURE ONLY: STAPHYLOCOCCUS EPIDERMIDIS. IN OCTOBER 8 A GRAM STAIN PRELIMINARY SHOWED: POLYMORPHONUCLEAR CELLS PRESENT / RARE SQUAMOUS EPITHELIAL CELLS / RARE GRAM-POSITIVE COCCI. CULTURE - CSF PRELIMINARY - SCANT GROWTH OF STAPHYLOCOCCUS EPIDERMIDIS. THEREFORE, THE EVD SYSTEM WAS CHANGED, NOT THE CATHETER. A LEUKOPLAST, ALSO KNOWN AS COVERPLAST FABRIC DRESSING, WAS USED ON THE INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011434 CODMAN BACTISEAL EVD CATHETER BACTISEAL EVD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 7328489 10381780515593

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other EDS3 SYSTEM - SKU (B)(4).