BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 20087135 · Received August 28, 2024

    Report

    Report Number
    3013886523-2024-00262
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    July 29, 2024
    Report Date
    February 14, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    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: G3, G6, H2, H3, H11. ADDITIONAL INFORMATION RECEIVED: "DURING THE IMPLANTATION, VENTRICULAR CATHETER PENETRATED CHORIOID PLEXUS. FEW DAYS AFTER THE IMPLANTATION, DIAGNOSTIC IMAGING CONFIRMED THAT THE VENTRICULAR CATHETER CAME OFF AND THE PERITONEAL CATHETER HAD FALLEN OFF. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024."

    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.

    Additional Manufacturer Narrative · 0

    HAKIM VALVE (ID (B)(6)) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3162 WITH LOT 7170029, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 70 MMH2O. THE VALVE WAS VISUALLY INSPECTED, AND NO DEFECT WAS NOTED. THE VALVE WAS HYDRATED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX AND SIPHON GUARD. THE VALVE WAS PRESSURE TESTED AND FAILED. THE VALVE WAS DISASSEMBLED. THE VALVE WAS VISUALLY INSPECTED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE MOTOR AND ON THE SEAT OF THE RUBY BALL AND ARM ASSEMBLY. ROOT CAUSE ANALYSIS - THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE IN VIEW OF THE BIOLOGICAL DEBRIS FOUND DURING THE INVESTIGATION.

    Description of Event or Problem · 0

    THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2024-00263, 3013886523-2024-00264. A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED DUE TO UNKNOWN REASON VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. AFTER THE PATIENT WAS BORN, SHE WAS TREATED WITH MENINGOCELE, AND AN OMMAYA RESERVOIR WAS IMPLANTED. THREE WEEKS AFTER BIRTH, THE HAKIM VALVE WAS IMPLANTED. THE VENTRICULAR CATHETER (ID NS0338) WAS IMPLANTED FROM DORSAL HORN, BUT IT PENETRATED CHOROID PLEXUS AND IT ENTERED TEMPORAL HORN. IN ADDITION, PERITONEAL CATHETER (ID NS0339) HAD COILED UP IN ABDOMINAL CAVITY. THEREFORE, DUE TO SUSPICION OF OBSTRUCTION; THE VALVE, VENTRICULAR AND PERITONEAL CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2024. THE PATIENT RECOVERED. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT HAD ANY SIGNS AND SYMPTOMS DUE TO THE PRODUCT PROBLEM.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480262 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Female Required Intervention PERITONEAL CATHETER (ID (B)(6))| VENTRICULAR CATHETER (ID (B)(6))