BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSITE

    MDR report key: 15548088 · Received October 6, 2022

    Report

    Report Number
    3006942524-2022-01309
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    May 20, 2022
    Report Date
    October 5, 2022
    Manufacturer
    PEROUSE MEDICAL
    Product Code
    LJT
    UDI-DI
    03661234017584
    PMA / PMN Number
    K122834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE MANUFACTURING BATCH RECORD OF THE POLYSITE 3017ISP IMPLANTABLE PORT FINAL PRODUCT (LOT 20100154) 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 179 UNITS MANUFACTURED IS IN ACCORDANCE WITH THE SPECIFICATIONS. NO DEVIATION WAS DETECTED. THE DEVICE HAS NOT BEEN RETURNED TO PEROUSE MEDICAL. UNFORTUNATELY, IN ABSENCE OF THE DEFECTIVE DEVICE, IT WAS NOT POSSIBLE TO PERFORM AN INVESTIGATION BY THE QUALITY CONTROL LAB. ACCORDING TO THE INFORMATION RECEIVED, THE SEPARATION OF THE CATHETER FROM THE PORT WAS DETECTED 4 WEEKS AFTER IMPLANTATION. REGARDING THE PHENOMENON OF SEPARATION OF THE CATHETER FROM THE PORT ONLY 4 WEEKS AFTER IMPLANTATION, THE MOST PROBABLE ROOT CAUSE WOULD BE A BAD CONNECTION OF THE CATHETER AT THE TIME OF IMPLANTATION. HOWEVER, IN THE ABSENCE OF ADDITIONAL INFORMATION, IT IS NOT POSSIBLE TO CONFIRM THIS HYPOTHESIS AND TO PRECISELY IDENTIFY THE ORIGIN OF THE INCIDENT REPORTED. CONSEQUENTLY, THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BEEN PRECISELY DETERMINED. PEROUSE MEDICAL HASN'T BEEN INFORMED OF OTHER INCIDENTS IMPLYING THE BATCH 20100154. 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® PORTS (SECTION IV-C : PORT INSERTION PROCEDURE OF POLYSITE® - IFU # CD00632_003).

    Description of Event or Problem · 0

    PORT 3017SPI PLACED ON (B)(6) 2022. ON (B)(6) 2022, FACILITY WAS UNABLE TO DO A BLOOD DRAW. UNDER SCAN, FACILITY NOTICED THAT THE CATHETER HAD "DETACHED" FROM THE PORT. DOCTOR USED A SNARE TO RETRIEVE THE CATHETER AND REMOVED THE PORT. UNDER EVALUATION, IT WAS STATED THE CATHETER DID NOT LOOK PUNCTURED, AND RATHER THAT IT JUST DETACHED. PATIENT IS GOING TO RECEIVE A PICC LINE INSTED OF A PORT GOING FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077762 POLYSITE PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT PEROUSE MEDICAL 3017SPI 20100154 03661234017584

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention