BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA LOW PROFILE PORT

    MDR report key: 1902949 · Received October 29, 2010

    Report

    Report Number
    2032582-2010-00006
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 17, 2010
    Report Date
    November 4, 2010
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJT
    PMA / PMN Number
    K073210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER FRACTURE SEEMS TO BE DUE TO A GRADE 3 PINCH-OFF. THE CATHETER FAILED IN FATIGUE RESULTING FROM CLAMPING AND DECLAMPING. SUCH EFFECT IS VERY WELL DESCRIBED IN THE LITERATURE AND IN OUR INSTRUCTION FOR USE. TE CLINICAL SIGNS OF THIS PINCH-OFF WAS MET 'INFUSION NURSE WAS RECEIVING NO BLOOD RETURN". A GRADE 3 PINCH-OFF RESULTS ON A CATHETER FRACTURE AND THE RECOMMENDATION OF THE EXPLANTATION WAS FOLLOWED BY THE SURGEON. THIS RISK IS IDENTIFIED IN OUR RISK ANALYSIS (ACCORDING TO ISO14971). THE REVIEW OF THE INSTRUCTIONS FOR USE SHOWS DETAILED/ADEQUATE INSTRUCTION FOR PORT CATHETER PLACEMENT AND PINCH-OFF WARNING. WE ATTRIBUTE THE REPORTED DEFECT TO AN INCORRECT HANDLING OF THE SURGICAL TECHNIQUE, WHICH RESULTS ON A GRADE-3 PINCH-OFF WITH CATHETER FRACTURE. (B)(6) (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED "PER DR (B)(6), XCELA PORT WAS NO LONGER FUNCTIONING, SO HE EXPLANTED. UPON EXPLANTING THE DEVICE, DR (B)(6) NOTICED THE CATHETER WAS FRACTURED. HE REMOVED THE PORT, AND THE PIECES OF THE CATHETER. SURGEON DID NOT PLACE ANOTHER PORT INSIDE THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCELA LOW PROFILE PORT IMPLANTED PORT AND CATHETER SYSTEM LJT PFM MEDICAL, INC 0949CS

    Patients

    Seq Age Sex Outcome Treatment
    1