BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLINE VLV W/ SPHNGRD

    MDR report key: 10653516 · Received October 8, 2020

    Report

    Report Number
    3013886523-2020-00150
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    September 18, 2020
    Report Date
    September 21, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D10, G4, G7,H2, H3, H6, H10 UNIQUE DEVICE IDENTIFIER (UDI) : (B)(4). THE CERTAS VALVE WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 2. THE VALVE WAS VISUALLY INSPECTED; THE SILICONE HOUSING WAS CUT/TORN AROUND THE SIPHON GUARD AND A MARK IN THE SIPHON GUARD WAS ALSO NOTED. THE VALVE WAS HYDRATED. THE VALVE WAS FLUSHED NO OCCLUSION WAS NOTED AT THE RUBY BALL BUT LEAKED FROM THE CUT/TEAR IN THE SILICONE HOUSING AROUND THE SIPHON GUARD. THE VALVE WAS LEAK TESTED AND LEAKED FROM THE TEAR/CUT IN THE SILICONE HOUSING AROUND THE SIPHON GUARD. THE VALVE COULD NOT BE REFLUX TESTED DUE TO THE DAMAGE SILICONE HOUSING. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS DUE TO THE CUT/TEAR IN THE SILICONE HOUSING AROUND THE SIPHON GUARD, THIS WAS PROBABLY CAUSED BY A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING, AS NOTED IN THE INSTRUCTION FOR USE (IFU) SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED A THAT ON (B)(6) 2020 A CERTAS VALVE WAS IMPLANTED AND MALFUNCTIONED ON (B)(6) 2020. THE PATIENT PRESENTED WITH A RETURN IN PREVIOUS SYMPTOMS OF CONFUSION, DROWSINESS, AND DIFFICULTY IN WALKING. THE PATIENT UNDERWENT MAGNETIC RESONANCE IMAGING THAT DEMONSTRATED VENTRICULAR ENLARGEMENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A SHUNT REVISION ON (B)(6) 2020 TO EXPLANT THE CERTAS PLUS VALVE (CODE 828805) WITH A CERTAS PLUS VALVE (CODE 828800, LOT # 193253) AND A BACTISEAL CATHETER (CODE 82-3072, LOT # 4245164). WHEN REMOVING THE SHUNT VALVE, IT WAS DISCOVERED THE SIPHON GUARD WAS INTERRUPTING THE PASSAGE OF CEREBROSPINAL FLUID AND NOT DRAINING CEREBROSPINAL FLUID. THE PATIENT HAD NO REPORTED TRAUMATIC EVENTS THAT MAY HAVE CONTRIBUTED TO THE SHUNT MALFUNCTION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115624 CERTAS INLINE VLV W/ SPHNGRD CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1