BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 12512844 · Received September 22, 2021

    Report

    Report Number
    3013886523-2021-00400
    Event Type
    Injury
    Date Received
    September 22, 2021
    Date of Event
    September 7, 2021
    Report Date
    November 15, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3832 WITH LOT 4515943 SHOWED 1 NR-REPORT (NC-100358) WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; SOME NEEDLE HOLES WERE NOTED IN THE NEEDLE CHAMBER, AND A CUT/TEAR ON THE SIDE OF THE VALVE NEAR THE PROXIMAL CONNECTOR. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 40MMH2O. THE VALVE WAS HYDRATED. THE VALVE WAS LEAK TESTED AND FAILED AND LEAKED FROM THE CUT/TEAR/NEEDLE HOLES IN THE SILICON HOUSING. THE VALVE WAS THEN PRESSURE TESTED ACCORDING TO TEST METHOD AND FAILED DUE TO THE CUT/TEAR IN THE SILICONE HOUSING. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX AND SIPHON GUARD. THE ROOT CAUSE FOR THE ¿PATIENT WAS FOUND TO HAVE NO CSF FLOWING OUT FROM THE ABDOMINAL CATHETER¿ COULD NOT BE DETERMINED AS NO OCCLUSION WAS NOTED WITH THE VALVE AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ¿PATIENT WAS FOUND TO HAVE NO "CSF" FLOWING OUT FROM THE ABDOMINAL CATHETER¿ IS PROBABLY DUE TO THE CUT/TEAR IN THE SILICONE HOUSING AT THE PROXIMAL END OF THE VALVE. THE ROOT CAUSE FOR THE CUT/TEAR IN THE SILICONE HOUSING NEAR THE PROXIMAL CONNECTOR IS DUE TO WRONG HANDLING, AS NOTED IN THE IFU: SILICONE HAS A LOW CUT/TEAR RESISTANCE. DO NOT USE SHARP INSTRUMENTS WHEN HANDLING THE SILICONE VALVE OR CATHETER, USE SHOD FORCEPS. CUTS OR ABRASIONS FROM SHARP INSTRUMENTS MAY RUPTURE OR TEAR THE SILICONE COMPONENTS.

    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

    A FACILITY REPORTED A HAKIM VALVE WITH SIPHONGUARD WAS IMPLANTED IN A PATIENT ON (B)(6) 2021. AFTER THE PROCEDURE, THE PATIENT WAS FOUND WITH AN ENCEPHALOCELE. ON (B)(6) 2021 A VENTRICULOMEGALY FOUND AND THERE WAS NO OBVIOUS IMPROVEMENT OF THE HYDROCEPHALUS THROUGH "CT" CHECK. ON (B)(6) 2021, IT WAS FOUND OUT THE THERE WAS NO CEREBROSPINAL FLUID FLOWING OUT OF THE ABDOMINAL CATHETER THROUGH "CT" CHECK. ON (B)(6) 2021, THE PHYSICIAN CONDUCTED THE REVISION PROCEDURE AND CHANGED THE VALVE WITH ANOTHER OF THE SAME DEVICE DUE TO SUSPICION OF OCCLUSION. PATIENT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411536 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 4515943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown