BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSITE

    MDR report key: 8600372 · Received May 10, 2019

    Report

    Report Number
    3006942524-2019-00001
    Event Type
    Injury
    Date Received
    May 10, 2019
    Report Date
    July 19, 2018
    Manufacturer
    PEROUSE MEDICAL
    Product Code
    LJT
    UDI-DI
    03661234017584
    PMA / PMN Number
    K122834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN ABSENCE OF THE DEFECTIVE DEVICE AND THE BATCH NUMBER, IT WAS NOT POSSIBLE TO PERFORM: A REVIEW OF THE BATCH RECORD; A DEEPER EXPERTISE OF THE DEFECT BY THE QUALITY CONTROL LAB. CONSEQUENTLY, THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BEEN PRECISELY DETERMINED. ACCORDING TO THE INFORMATION RECEIVED: THE DEVICE WAS IMPLANTED ON (B)(6) 2018 AND THE INCIDENT WAS OBSERVED ON (B)(6) 2018, MORE THAN MONTHS AFTER IMPLANTATION. REGARDING THE PHENOMENON OF SEPARATION OF THE CATHETER FROM THE PORT, THE MOST LIKELY ROOT CAUSE WOULD BE A BAD CONNECTION OF THE CATHETER AT THE TIME OF THE IMPLANTATION. UNFORTUNATELY, THE FOLLOWING INFORMATION (VENOUS ACCESS ROUTES, IMPLANTATION REPORT, COPY X-RAY IMPLANTATION, COPY XRAY EVENT) ARE NOT AVAILABLE IN THE NOTIFICATION SUMMARY TRANSMITTED BY THE FDA. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO US. SO IT IS NOT POSSIBLE TO CONFIRM THIS HYPOTHESIS AND TO PRECISELY IDENTIFY THE ORIGIN OF THE INCIDENT REPORTED. NO SIMILAR INCIDENT HAS BEEN RECORDED FOR POLYSITE REFERENCE 3017SPI. FURTHERMORE, THE DIFFERENT STEPS FOR THE FIXATION OF THE CATHETER ON THE IMPLANTABLE PORT ARE PRECISELY DESCRIBED IN THE INSTRUCTION FOR USE (IFU) OF POLYSITE IMPLANTABLE PORTS (SECTION IV-C: PORT INSERTION PROCEDURE OF POLYSITE PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT - IFU# CD00632_001). OTHER REMARKS: LOT #, SERIAL #, UDI #: BECAUSE THE BATCH NUMBER AND SERIAL NUMBER ARE UNKNOWN, THE COMPLETE UDI IS NOT AVAILABLE. ONLY THE PRIMARY DI HAS BEEN DOCUMENTED (THE PACKAGE DI IS (B)(4)).

    Description of Event or Problem · 1

    ACCORDING TO THE MEDWATCH (MW5081802): "UPON REMOVAL OF MEDIPORT IT WAS NOTED THAT THE CONNECTOR WAS NOT ATTACHED TO THE PORT ITSELF. FLUOROSCOPY WAS USED TO DETERMINE WHERE OR IF CONNECTOR WAS STILL IN THE PATIENT. BLUNT DISSECTION WAS UTILIZED TO RETRIEVE CONNECTOR WITH HEMOSTATS. NO DANGER TO PATIENT WAS NOTED AND NO POST PROCEDURE COMPLICATION WAS NOTED". THIS INFORMATION HAS BEEN RECEIVED FROM THE DISTRIBUTOR (B)(4) ON 02 JAN 2019 AT PEROUSE MEDICAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394457 POLYSITE PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT LJT PEROUSE MEDICAL 3017SPI UNKNOWN 03661234017584

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention