BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYSITE

    MDR report key: 18650587 · Received February 6, 2024

    Report

    Report Number
    2245270-2024-00014
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    December 1, 2023
    Report Date
    March 8, 2024
    Manufacturer
    PEROUSE MEDICAL
    Product Code
    LJT
    UDI-DI
    03661234017584
    PMA / PMN Number
    K122834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE MALFUNCTIONING DEVICE WAS NOT RETURNED TO VYGON, THE DETAILS OF THE MALFUNCTION WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO THE FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 0

    WE CONTACTED THE CUSTOMER AND ASKED FOR MORE DETAILS ABOUT THE INCIDENT. THE CUSTOMER HAS INFORMED US THAT THERE IS NO DEFECTIVE PRODUCT TO RETURN, AND NO FURTHER DETAILS CAN BE PROVIDED ABOUT THE INSERTION SITE OR THE DEVICE PROBLEM AND WHY THE PORT HAD TO BE REMOVED, OTHER THAN AS STATED IN THE INCIDENT DESCRIPTION. AS A RESULT, THIS COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE OF THE ISSUE CANNOT BE ESTABLISHED. THE MOST LIKELY HYPOTHESIS THAT COULD EXPLAIN THE EXTERNALIZATION PHENOMENON FROM THE IMPLANTABLE PORT COULD BE: · THE USE OF AN IMPLANTABLE PORT NOT ADAPTED TO THE PATIENT'S MORPHOLOGY (DIMENSION (TOO LARGE), MATERIAL, INDICATION. AN IMPLANTABLE PORT LOCATED LESS THAN 1 CM FROM THE SKIN. WEIGHT LOSS OF THE PATIENT, THE WEAKENING OF THE PATIENT'S SKIN BY CHEMO PRODUCTS. UNFORTUNATELY, WITHOUT ADDITIONAL INFORMATION AND REGARDING OUR INVESTIGATION, IT IS NOT POSSIBLE TO CONFIRM THESE HYPOTHESES. THE REVIEW OF THE MANUFACTURING BATCH RECORD OF THE POLYSITE 3017SPI IMPLANTABLE PORT FINAL PRODUCT (LOT 22090085) DID NOT HIGHLIGHT ANY DEVIATION THAT COULD BE THE ROOT CAUSE OF THE INCIDENT. PEROUSE MEDICAL HAS BEEN MADE AWARE OF TWO SIMILAR INCIDENTS INVOLVING THIS LOT 22090085, BOTH REPORTED FROM THE SAME HOSPITAL CENTER. PEROUSE MEDICAL HAS NOT RECORDED SIMILAR INCIDENTS OF PORT EXTERNALIZATION BETWEEN 2020 AND 2023 ACROSS ALL ITS IMPLANTABLE CATHETER PORTS. ON THE OTHER HAND, WE HAVE BEEN INFORMED OF FOUR SIMILAR INCIDENTS IN 2024 OCCURRING IN THE SAME HOSPITAL. CORRECTIVE ACTION: DUE TO THE MISSING SAMPLE AND FURTHER INFORMATION THIS COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE OF THIS ISSUE CANNOT BE ESTABLISHED. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT.

    Description of Event or Problem · 0

    PORT INSERTION SITE OPENED UP. REQUIRED PORT REMOVAL.

    Description of Event or Problem · 0

    PORT INSERTION SITE OPENED UP. REQUIRED PORT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955872 POLYSITE POLYSITE IMPLANTABLE PORTS LJT PEROUSE MEDICAL 3017SPI 22090085 03661234017584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention