BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEROUSE MEDICAL

    MDR report key: 8865085 · Received August 6, 2019

    Report

    Report Number
    3006942524-2018-01473
    Event Type
    Injury
    Date Received
    August 6, 2019
    Report Date
    August 1, 2019
    Manufacturer
    PEROUSE MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K122834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW: BOTH VISUAL INSPECTION AND TIGHTNESS TESTS CARRIED OUT ON 100% OF THE UNITS DID NOT HIGHLIGHT ANY ANOMALY OR IT WOULD HAVE PROBABLY BEEN DETECTED BY OUR OPERATORS DURING PRODUCTION OPERATIONS. IF WE RELY ON THE DESCRIPTION OF THE EVENT THE MOST LIKELY HYPOTHESIS THAT COULD EXPLAIN THE SEPARATION OF THE CATHETER FROM THE PORT WOULD BE A BAD CONNECTION AT THE TIME OF THE IMPLANTATION: IT SEEMS THAT "THE PORT WAS ASSEMBLED BACKWARD". IF THE CONNECTION RING IS INSERTED BACKWARD ON THE CATHETER THE WITHDRAWAL FORCE OF THE CATHETER IS DECREASED AND COULD LEAD TO DISCONNECTION. FURTHERMORE, THE DIFFERENT STEPS OF THE FIXATION OF THE CATHETER ON THE IMPLANTABLE PORT ARE PRECISELY DESCRIBED AND SCHEMATIZED IN THE IFU AND HAS TO BE FOLLOWED (SECTION IV-C: PORT INSETION PROCEDURE OF POLYSITE PRESSURE INJECTABLE IMPLATABLE INFUSION PORT - IFU#(B)(4)). HOWEVER, IN THE ABSENCE OF THE INCRIMINATED DEVICES AND FURTHER CLINICAL INFORMATION, IT IS NOT POSSIBLE TO CONFIRM THERE HYPOTHESIS AND TO PRECISELY IDENTIFY THE ORIGIN OF THE INCIDENT REPORTED. PEROUSE MEDICAL (PM) HAS NOT BEEN INFORMED OF ANY SIMILAR INCIDENTS IMPLYING THESE BATCHED. THE CUSTOMER WAS ADVISED TO KEEP THE INCRIMINATED DEVICES SHOULD SUCH INCIDENT HAPPENS AGAIN. THE INCRIMINATED MEDICAL DEVICE WAS NOT RECEIVED. PM HAS NOT BEEN INFORMED OF ANY SIMILAR INCIDENTS IMPLYING THE BATCH (B)(4). THE DISTRIBUTOR HAS BEEN ADVISED TO CONTACT AND TO SENSIBILIZE THE CUSTOMER TO THE HANDLING OF THE POLYSITE PRODUCTS. OTHER REMARKS: SN #(B)(4) IS CORRESPONDING TO BATCH #(B)(4). THE REPORT MENTIONS ANOTHER CASE OF PORT REMOVAL, BATCH NUMBER INFORMATION IS NOT AVAILABLE AND TO BE CONFIRMED. ANOTHER BATCH NUMBER WAS MENTIONED IN THE COMPLAINT FORM WE RECEIVED FROM TELEFLEX (BATCH#(B)(6)). THE EVENT DATE CAN NOT BE (B)(6) 2016 SINCE BOTH BATCHES HAVE BEEN MANUFACTURED ON 2017. CONFIRMATION OF THE DATA AND FURTHER INFORMATION HAVE BEEN REQUESTED TO THE CUSTOMER SINCE PEROUSE MEDICAL HAS BEEN MADE AWARE OF THE INCIDENT, BUT NO FURTHER INFORMATION WAS PROVIDED SO FAR. (DATES OF REQUESTS: (B)(6) 2018).

    Description of Event or Problem · 1

    ACCORDING TO THE MEDWATCH (B)(4) "THE PORT WAS ASSEMBLED BACKWARD AND CAME APART INSIDE THE PATIENT CAUSING THE PATIENT TO NEED ANOTHER PROCEDURE TO REMOVE THE DISLODGED PIECE AND TO HAVE A NEW PORT PLACED. UPON REVIEWING ALL THE CASES WE DID WITH THIS PORT, WE FOUND A TOTAL OF FOUR PATIENTS WHO HAD THE DEVICE PUT IN BACKWARDS. TWO PATIENTS HAD SURGERY TO REPLACE THEIR PORT. THE OTHER TWO PATIENTS HAVE SO FAR DECLINED A REPLACEMENT PORT AS THEY WERE PLACED A YEAR AGO AND THERE IS LIKELY SCAR TISSUE HOLDING THEM TOGETHER". THE MEDIPORT WAS PLACED IN THE ORIGINAL PROCEDURE FOR CHEMOTHERAPY INFUSION. THERE WAS NO HARM REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658771 PEROUSE MEDICAL PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT LJT PEROUSE MEDICAL POLYSITE 17100189

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention