BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BACTISEAL CATHETER KIT

    MDR report key: 11283284 · Received February 4, 2021

    Report

    Report Number
    3013886523-2021-00066
    Event Type
    Injury
    Date Received
    February 4, 2021
    Date of Event
    January 12, 2021
    Report Date
    May 26, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K102589
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE BACTISEAL CATHTER WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS - THE RECEIVED CATHETERS WERE VISUALLY INSPECTED; SOME CUT/TORN WAS NOTED IN ONE EXTREMITY OF THE PERITONEAL CATHETER. THE VENTRICULAR CATHETER WAS CUT/TORN IN TWO PARTS. THE CATHETERS WERE IRRIGATED; NO OCCLUSION WAS NOTED. THE COMPLAINT COULD NOT BE CONFIRMED. THE CATHETERS WERE LEAK TESTED; NO LEAKAGE WAS NOTED WHEN CONNECTED WITH CONNECTORS. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE CATHETERS AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE "OCCLUSION" REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILDUP INTERFERING WITH THE DEVICE. AT THE TIME OF INVESTIGATION, NO OCCLUSION ISSUES WERE NOTED. THE ROOT CAUSE FOR THE CUT/TEARS NOTED DURING THE INVESTIGATION COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE. AS NOTED IN THE IFU, IN THE SECTION 'PRECAUTIONS': "DO NOT USE SHARP INSTRUMENTS WHEN HANDLING THIS PRODUCT. USE SHOD FORCEPS. SILICONE HAS A LOW CUT AND TEAR RESISTANCE; THEREFORE, EXERCISE CARE WHEN PLACING LIGATURES SO AS NOT TO TIE THEM TOO TIGHTLY. THE USE OF STAINLESS STEEL LIGATURES ON SILICONE RUBBER IS NOT RECOMMENDED".

    Description of Event or Problem · 0

    N/A.

    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

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2021-00064 A PHYSICIAN REPORTED THAT THE CODMAN CERTAS VALVE WAS IMPLANTED IN A MALE PATIENT, (B)(6) YEARS OLD, WITH A CHILDHOOD GLIOMA VIA A V-P SHUNT WHICH WAS CONNECTED TO A BACTISEAL CATHETER (823072). THE SETTING WAS SET AT 5. ON (B)(6) 2021 VENTRICULAR ENLARGEMENT WAS CONFIRMED AND THAT UNDER DRAINAGE AND SUBCUTANEOUS CSF RETENTION WERE OBSERVED. THE SHUNT SYSTEM WAS FUNCTIONING AS THE CSF WAS ABLE TO BE DRAINED BY PUMPING MULTIPLE TIMES. THE SETTING WAS THEN CHANGED TO 2. AS OF (B)(6) 2021, NO IMPROVEMENT OF HYDROCEPHALUS WAS NOTED. ON (B)(6) RECONSTRUCTION SURGERY WAS PERFORMED, AND THE VENTRICULAR CATHETER PLACED IN DECEMBER WAS REMOVED, AND REPLACED WITH THE VENTRICULAR CATHETER SET 823003. PUMPING WAS DONE BEFORE RECONSTRUCTION SURGERY, BUT THE SUSPICION OF OBSTRUCTION DID NOT IMPROVE. THERE IS A POSSIBILITY THAT IT WAS OPENED WHEN PUMPING WAS PERFORMED AFTER REMOVAL. DUE TO THE INFLUENCE OF THE UNDERLYING DISEASE, THE PATIENT¿S PROTEIN CONCENTRATION INCREASED WITH EACH PASSING DAY, WITH THE LATEST BEING 290 MG/ML WHICH MAY ALSO BE DUE TO OBSTRUCTION. THE PATIENT¿S CONDITION POSTOPERATIVELY WAS GOOD AND IS IN RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177029 CODMAN BACTISEAL CATHETER KIT BACTISEAL CATHETER KIT JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 0 MO