BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSITE

    MDR report key: 9282069 · Received November 5, 2019

    Report

    Report Number
    3004160911-2019-03043
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    October 4, 2019
    Report Date
    November 5, 2019
    Manufacturer
    PEROUSE MEDICAL
    Product Code
    LJT
    UDI-DI
    03661234017584
    PMA / PMN Number
    K122834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING BATCH RECORD OF THE POLYSITE 3017SPI IMPLANTABLE PORT FINAL PRODUCT (LOT 18070056) DID NOT HIGHLIGHT ANY DEVIATION THAT COULD BE THE ROOT CAUSE OF THE INCIDENT. INDEED, THE SEALING OF THE PORT-CATHETER-CONNECTION RING ASSEMBLY IS VERIFIED ON 100% OF THE DEVICES MANUFACTURED BY INJECTING AIR AT A PRESSURE OF 2.2 BAR +/_ 0.2 BAR FOR 1 MINUTE. ALTERATION OF THE CATHETER OR CONNECTING RING WOULD MOST LIKELY HAVE LED TO A LEAKAGE AND WOULD HAVE BEEN DETECTED. THE LEAK TEST PERFORMED ON THE 168 UNITS MANUFACTURED IS IN ACCORDANCE WITH THE SPECIFICATIONS. NO DEVIATIONS WERE DETECTED. UNFORTUNATELY, IN ABSENCE OF THE DEFECTIVE DEVICE, IT WAS NOT POSSIBLE TO PERFORM AN INVESTIGATION BY THE QUALITY CONTROL LAB. REGARDING THE PHENOMENON OF SEPARATION OF THE CATHETER FROM THE PORT, THE MOST LIKELY ROOT CAUSE WOULD BE AN INSUFFICIENT CONNECTION OF THE CATHETER TO THE PORT HOUSING AT THE TIME OF IMPLANTATION. THE CATHETER MIGHT NOT HAVE BEEN ADVANCED ENOUGH ON THE TITANIUM TUBE. UNFORTUNATELY, IN THE ABSENCE OF THE DEFECTIVE DEVICE AND FURTHER CLINICAL INFORMATION (IMPLANTATION/EXPLANTATION REPORTS AND COPY OF X-RAY), IT WAS NOT POSSIBLE TO PERFORM DEEP EXPERTISE OF THE INCIDENT IN ORDER TO CONFIRM THIS HYPOTHESIS. PEROUSE MEDICAL HAS NOT BEEN INFORMED OF OTHER INCIDENT INVOLVING THE BATCH 18070056. BASED ON THE POTENTIAL ROOT CAUSE, NO CORRECTIVE ACTION HAS BEEN INITIATED. HOWEVER, IT WAS REMINDED THAT 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 # (B)(4)). (THE PACKAGE DI IS (B)(4)). UF/IMPORTER REPORT # (B)(6).

    Description of Event or Problem · 1

    ACCORDING TO THE TELEFLEX NOTIFICATION SUMMARY REFERENCE (B)(4) RECEIVED ON OCTOBER 8TH 2019: "THE CATHETER DISLODGED FROM THE PORT INSIDE THE PATIENT. THEY HAD TO USE A SNARE TO REMOVE THE CATHETER ENDOVASCULARLY AND THEY REVISED THE PORT ANOTHER DAY ." THIS INCIDENT TOOK PLACE IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074308 POLYSITE PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT LJT PEROUSE MEDICAL 3017SPI 18070056 03661234017584

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention