BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 20472910 · Received October 17, 2024

    Report

    Report Number
    3013886523-2024-00322
    Event Type
    Injury
    Date Received
    October 17, 2024
    Date of Event
    August 12, 2024
    Report Date
    January 9, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519232
    PMA / PMN Number
    K221840
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: WERE ALL THE BROKEN PARTS RECOVERED? "YES." WAS THERE ANY FAILURE OBSERVED ON THE CODMAN BACTISEAL CATHETER KIT (ID 823072)? IF YES, A. PLEASE SPECIFY THE FAILURE: "NO FAILURE." B. WAS THE CATHETER REMOVED AND REPLACED? "NO."

    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 6331803, 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; THE SIPHON GUARD WAS BROKEN. CUT AND TEAR MARK WERE NOTED ON THE SIPHON GUARD AND HOUSING. THE COMPLAINT WAS CONFIRMED. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE ¿SIPHON BROKEN¿ COULD BE 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 IFU, SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID 823162) AND A BACTISEAL CATHETER KIT (ID 823072) WERE IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT FELT DIZZY AND IN (B)(6) 2024, THE PRESSURE OF THE VALVE WAS ADJUSTED TO 90MMH2O. ON (B)(6) 2024, THE PHYSICIAN CONDUCTED A REVISION PROCEDURE AND FOUND THAT THE VALVE WAS BROKEN. THEN THE VALVE WAS REMOVED AND REPLACED. AFTER THE PROCEDURE, THE PATIENT FELT BETTER. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS, THEREFORE, IT IS UNKNOWN IF THE BACTISEAL CATHETER FAILED, AND IF THE CATHETER WAS ALSO REMOVED/REPLACED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368324 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 6331803 10381780519232

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention BACTISEAL CATHETER KIT (ID: 823072).