BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 20081743 · Received August 27, 2024

    Report

    Report Number
    3013886523-2024-00258
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    July 27, 2024
    Report Date
    December 27, 2024
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780534570
    PMA / PMN Number
    K221840
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G3, G6, H2, H3, H4, H6, H11. THE HAKIM VALVE (ID 823162) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO NOT SECURING THE CATHETER WHEN IMPLANTED. HOWEVER, IT WAS NOT POSSIBLE TO CONFIRM AND IDENTIFY THE ROOT CAUSE OF THIS ASSUMPTION AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE (ID 823162) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3162 WITH LOT 4175406, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 80 MMH2O. THE VALVE WAS VISUALLY INSPECTED; CONNECTOR WAS MISSING, AND CATHETER NOT RECEIVED. A CUT MARK WAS NOTED ON THE HOUSING. THE VALVE WAS TESTED FOR PROGRAMMING; THE VALVE FAILED THE TEST. THE VALVE PASSED THE TEST FOR OCCLUSION, LEAK, REFLUX, AND SIPHON GUARD. THE PRESSURE TEST COULD NOT BE PERFORMED AS THE DEVICE COULD NOT BE PROGRAMMED. THE VALVE WAS VISUALLY INSPECTED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION; BIOLOGICAL DEBRIS WAS FOUND ON THE RUBY BALL, MOTOR AND ON THE SEAT OF THE RUBY BALL. ROOT CAUSE ANALYSIS - THE POSSIBLE ROOT CAUSE FOR THE VENTRICULAR CONNECTOR AND MISSING PROXIMAL CONNECTOR COULD BE DUE TO ATYPICAL HANDLING DURING THE IMPLANTATION. HOWEVER, IT WAS NOT POSSIBLE TO CONFIRM AND IDENTIFY THE ROOT CAUSE OF THIS ASSUMPTION AS THE CATHETER WAS NOT RETURNED FOR INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE PROGRAMMING ISSUE IS DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE. THE ROOT CAUSE FOR THE ¿CUT MARKS¿ IS DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE VALVE OR ATYPICAL HANDLING, AS NOTED IN THE SURGICAL PROCEDURE PRECAUTIONS SECTION IN INSTRUCTION FOR USE (IFU), SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    Additional Manufacturer Narrative · 0

    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 · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2024-00259. A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED DUE TO NORMAL PRESSURE HYDROCEPHALUS (NPH) VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE VALVE WAS USED ALONG WITH THE VENTRICULAR CATHETER (ID 823073) AND PERITONEAL CATHETER (ID 823074). THE PATIENT IS A 3.5 YEAR-OLD MALE, AND THE VALVE AND CATHETERS WERE IMPLANTED WHEN THE PATIENT WAS 5 MONTHS OLD. ON (B)(6) 2024, THE CONSCIOUSNESS LEVEL OF THE PATIENT HAD DECLINED AND WAS VOMITING. A SLIT-LIKE VENTRICLE WAS OBSERVED ON X-RAY, AND CT SCAN SHOWED THAT THE VENTRICULAR CATHETER (ID 823073) HAD FALLEN OFF. A REVISION SURGERY WAS PERFORMED, THE VALVE AND THE VENTRICULAR CATHETER WERE EXPLANTED AND REPLACED WITH A NEW DEVICE ON (B)(6) 2024 EXCEPT FOR THE PERITONEAL CATHETER. THERE IS NO ISSUE WITH THE PERITONEAL CATHETER. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521503 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 10381780534570

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male Required Intervention PERITONEAL CATHETER (ID 823074.| VENTRICULAR CATHETER (ID 823073.