BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 19487694 · Received June 7, 2024

    Report

    Report Number
    3013886523-2024-00166
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    April 26, 2024
    Report Date
    August 22, 2024
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780519232
    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

    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

    THE HAKIM VALVE (ID 823162) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) ¿ THE PRODUCT CODE 82-3162 WITH LOT 5635831, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; A NEEDLE HOLE IN THE NEEDLE CHAMBER WAS NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. THE VALVE WAS LEAK TESTED; ONLY LEAKED FROM NEEDLE HOLE IN NEEDLE CHAMBER. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX, SIPHON GUARD AND PRESSURE. ROOT CAUSE ANALYSIS - NO ROOT CAUSE COULD BE DETERMINED FOR THE ISSUE REPORTED BY THE CUSTOMER AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEMS WITH THE VALVE AT THE TIME OF INVESTIGATION. A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE. AT THE TIME OF INVESTIGATION, NO OCCLUSIONS WERE NOTED WITH THE VALVE.

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2024-00132. A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED DUE TO UNKNOWN REASON VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. DUE TO SUSPICION OF OBSTRUCTION, A REVISION SURGERY WAS PERFORMED. THE VALVE WAS REMOVED AND REPLACED WITH ID 823162 AND A DIFFERENT LOT NUMBER ON APRIL 26, 2024. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO SUSPECTED OBSTRUCTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1578509 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 5635831 10381780519232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention BACTISEAL PERITONEAL CATHETER (823074).| BACTISEAL VENTRICULAR CATHETER (823073).