BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV ONLY W/SPHNGD

    MDR report key: 10841094 · Received November 14, 2020

    Report

    Report Number
    3013886523-2020-00192
    Event Type
    Injury
    Date Received
    November 14, 2020
    Date of Event
    October 22, 2020
    Report Date
    October 22, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). THE VALVE WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR): CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 3. THE VALVE WAS VISUALLY INSPECTED; THE SILICONE HOUSING WAS CUT/TORN AROUND THE SIPHON GUARD THE COMPLAINT IS CONFIRMED. THE SIPHON GUARD WAS VISUALLY INSPECTED MARKS WERE NOTED IN THE SIPHON GUARD. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER THE VALVE HAS SPLIT DOWN THE MIDDLE, THIS WAS PROBABLY CAUSED BY A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING, AS NOTED IN THE "IFU" SILICONE HAS A LOW CUT/TEAR RESISTANCE. THE ROOT CAUSE FOR THE MARKS IN THE SIPHON GUARD WERE PROBABLY CAUSED BY A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SIPHON GUARD.

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFIER (UDI) : (B)(4). THE VALVE WAS NOT RETURNED FOR EVALUATION AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A.

    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

    THIS IS 1 OF 2 REPORTS. OTHER MFG REPORT NUMBER 3013886523-2020-00193. A FACILITY REPORTED THE CODMAN CERTAS VALVE WITH SG (MODEL 828804 )AND A PLAIN SILICON CATHETER (MODEL REFS 823041 AND 821684) WERE IMPLANTED TO A (B)(6) YEAR OLD MALE PATIENT ON OCTOBER 19. THREE DAYS POST OP, THE SURGEON NOTICED CSF LEAKING FROM THE INCISION SITE. ON OCTOBER 22, THE SURGEON TOOK THE PATIENT BACK TO THE OR AND THE CERTAS PLUS VALVE AND PERITONEAL CATHETER WERE REVISED (CATHETER MODEL REF 821684 HOLTER DISTAL PERITONEAL CATHETER). IT WAS NOTED THAT THE VALVE HAD SPLIT DOWN THE MIDDLE AND THE PERITONEAL CATHETER HAD DISLODGED AT THE VALVE CONNECTION POINT. THE SIPHON GUARD HAD COMPLETELY DISLODGED FROM THE VALVE. THE PATIENT DID NOT EXPERIENCE A FALL OR HIT TO THE HEAD POST OP AND THE SURGEON STATED THAT THEY DID NOT BEND THE VALVE ON INSERTION. THE VENTRICULAR CATHETER WAS NOT REVISED (MODEL REF 823041 HAKIM VENTRICULAR CATHETER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306353 CERTAS INLIN VLV ONLY W/SPHNGD CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 4706532

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR