BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BACTISEAL EVD CATHETER

    MDR report key: 11292972 · Received February 8, 2021

    Report

    Report Number
    3014334038-2021-00020
    Event Type
    Injury
    Date Received
    February 8, 2021
    Date of Event
    January 5, 2021
    Report Date
    July 30, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K102589
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BACTISEAL CATHETER WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-1745 WITH LOT NUMBER 4931215 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - ONLY 110MM OF CATHETER WAS RECEIVED. THE RETURNED CATHETER WAS VISUALLY INSPECTED; A CUT/TEAR WAS NOTED. THE CATHETER WAS LEAK TESTED AND FAILED. THE CATHETER LEAKED FROM THE CUT/TEAR IN THE SILICONE. HE CATHETER WAS FLUSHED AND NO OCCLUSION WAS NOTED. NO ROOT CAUSE COULD BE DETERMINED FOR THE ISSUE REPORTED BY THE CUSTOMER AS NO OCCLUSION WAS NOTED WITH THE RETURNED DEVICE. THE POSSIBLE ROOT CAUSE FOR THE "OCCLUSION" REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILDUP INTERFERING WITH THE DEVICE. BUT, AT THE TIME OF INVESTIGATION, NO OCCLUSION ISSUE WAS NOTED. THE ROOT CAUSE FOR THE CUT/TEAR NOTED DURING THE INVESTIGATION COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE. AS NOTED IN THE "IFU": "DO NOT USE SHARP INSTRUMENTS WHEN HANDLING THIS PRODUCT. USE SHOD FORCEPS SILICONE CUTS AND TEARS EASILY".

    Additional Manufacturer Narrative · 1

    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 · 1

    A FACILITY REPORTED A BLOCKED CODMAN BACTISEAL EXTERNAL VENTRICULAR DRAINAGE (EVD) CATHETER. A PATIENT HAD BILATERAL EXTERNAL VENTRICULOSTOMY CATHETERS INSERTED ON (B)(6) 2021; BOTH CODMAN BACTISEAL EXTERNAL VENTRICULAR DRAINAGE CATHETERS WERE IMPLANTED ON THE SAME DAY AND THE CHART DID NOT NOTE WHICH ONE WAS VENTRICULAR DRAIN WERE LEFT AND WHICH VENTRICULAR CATHETER WAS RIGHT AS THESE ARE NOT CONSIDERED IMPLANTS AND THE CHARTING REFLECTS THIS. ONE OF THE EXTERNAL VENTRICULAR DRAINAGE CATHETERS WAS REPORTEDLY NOT ABLE TO BE FLUSHED SO THE SURGEON REMOVED THE CATHETER. AFTER THE EXTERNAL VENTRICULAR DRAINAGE CATHETER WAS EXPLANTED THE RESIDENT ATTEMPTED TO FLUSH THE CATHETER. IT WAS REPORTED THAT THE CATHETER ¿JUST BLOW UP LIKE A BALLOON, NO FLUID WOULD PASS THROUGH.¿ THE SURGEON ¿THINKS THAT ONE OF THE LUMEN WALLS WAS TOO THIN AND THE SURGEON FELT THAT CATHETER WAS DEFECTIVE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194268 CODMAN BACTISEAL EVD CATHETER BACTISEAL EVD CATHETERS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1