BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIPHONGUARD, CSF FLD CONTRL DV

    MDR report key: 9348928 · Received November 20, 2019

    Report

    Report Number
    1226348-2019-00545
    Event Type
    Injury
    Date Received
    November 20, 2019
    Date of Event
    November 3, 2019
    Report Date
    November 3, 2019
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). THE SIPHON GUARD WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR)- PRODUCT 823090 WITH LOT 203979, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS- THE SIPHON GUARD WAS VISUALLY INSPECTED; THE SILICONE HOUSING AROUND THE SIPHON GUARD WAS DAMAGED. THE SIPHON GUARD WAS IRRIGATED NO OCCLUSIONS NOTED. THE SIPHON GUARD WAS LEAK TESTED LEAKS FROM SILICONE AROUND THE SIPHON GUARD WERE NOTED. MARKS WERE NOTED IN THE SIPHON GUARD. THE ROOT CAUSE FOR THE DAMAGE IN THE SILICONE HOUSING AROUND THE SIPHON GUARD REPORTED BY THE CUSTOMER IS DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE. AS NOTED IN THE INSTRUCTIONS FOR USE (IFU) SILICONE HAS A LOW TEAR/CUT RESISTANCE.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN EXTERNAL VENTRICULAR DRAIN AS TEMPORARY MEASURE. SINCE THE CEREBROSPINAL FLUID (CSF) PRESSURE WAS MEASURING ZERO, A CODMAN BACTISEAL CATHETER KIT (ID 823072) WAS IMPLANTED WITH A SIPHONGUARD (ID 823090). APPARENTLY THE SIPHONGUARD WAS USED INSTEAD OF THE VALVE THAT COMES WITH THE KIT. AFTER THE IMPLANTATION, NO CSF WAS DETECTED COMING OUT OF THE CATHETER, SO THE BACTISEAL DISTAL CATHETER WAS REMOVED AND REPLACED WITH A COMPETITOR CATHETER. TWO DAYS LATER, ANOTHER REVISION SURGERY WAS REQUIRED TO REMOVE THE SIPHONGUARD AND REPLACE IT WITH A COMPETITOR PRODUCT. IT WAS OBSERVED THAT THE EXPLANTED SIPHONGUARD HAD PIN HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144802 SIPHONGUARD, CSF FLD CONTRL DV OTHER ACCESSORIES JXG INTEGRA LIFESCIENCES MANSFIELD 203979

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR