BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSITE

    MDR report key: 19498523 · Received June 10, 2024

    Report

    Report Number
    2245270-2024-00050
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    December 7, 2023
    Report Date
    July 17, 2024
    Manufacturer
    PEROUSE MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K122834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE ARE TWO INCIDENTS THAT OCCURED WITH THIS COMPLAINT. ONE IS MDR # 2245270-2024-00026 AND THE OTHER IS . 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.

    Additional Manufacturer Narrative · 0

    THERE ARE TWO INCIDENTS THAT OCCURED WITH THIS COMPLAINT. ONE IS MDR # (B)(4). UNFORTUNATELY, WITHOUT THE DEFECTIVE DEVICE AND FURTHER INFORMATION, THE QUALITY CONTROL LAB COULD NOT CONDUCT A THOROUGH ANALYSIS OF THE DEFECT. DUE TO THIS, WE CANNOT CONFIRM THIS COMPLAINT, AND THE EXACT ROOT OF THE ISSUE CANNOT BE DETERMINED. SINCE NO BATCH NUMBER WAS PROVIDED, A DOCUMENTATION REVIEW COULD NOT BE CONDUCTED. PLEASE NOTE THAT ALL BATCHES ARE INSPECTED BEFORE RELEASE, AND INCOMING BATCHES OF INTRODUCERS WITH PEELABLE SHEATHS ARE ALSO CONTROLLED. THEREFORE, WE DO NOT BELIEVE THAT THIS INCIDENT IS RELATED TO A PRODUCT DEFECT. A 2-YEAR REVIEW OF COMPLAINTS DATA SHOWS THIS IS THE FIRST REPORTED COMPLAINT FOR THIS ISSUE AGAINST THE 3017SPI. CORRECTIVE ACTION: DUE TO THE MISSING DEFECTIVE DEVICE AND FURTHER INFORMATION, THIS COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE CANNOT BE DETERMINED THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED AT THIS TIME.

    Description of Event or Problem · 0

    THE PEEL AWAY SHEATH BROKE OFF DURING PEELING, LEAVING A PIECE UNDER SKIN. DOCTOR HAD TO RETRIEVE BROKEN PIECE AND VERIFIED NOTHING WAS LEFT IN THE PATIENT. OUTCOME WAS NO HARM TO PATIENT.

    Description of Event or Problem · 0

    THE PEEL AWAY SHEATH BROKE OFF DURING PEELING, LEAVING A PIECE UNDER SKIN. DOCTOR HAD TO RETRIEVE BROKEN PIECE AND VERIFIED NOTHING WAS LEFT IN THE PATIENT. OUTCOME WAS NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206342 POLYSITE POLYSITE IMPLANTABLE PORTS LJT PEROUSE MEDICAL 3017SPI NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown