BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS / XCELA

    MDR report key: 6777833 · Received August 9, 2017

    Report

    Report Number
    1317056-2017-00060
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    July 10, 2017
    Report Date
    September 19, 2017
    Manufacturer
    PFM MEDICAL
    Product Code
    LJT
    UDI-DI
    H965451810
    PMA / PMN Number
    K072481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE FROM THE REPORTED EVENT HAS BEEN RETURNED TO ANGIODYNAMICS. AS THIS PORT IS MANUFACTURED FOR ANGIODYNAMICS BY PFM MEDICAL, IT IS BEING FORWARD TO PFM FOR EVALUATION AND COMPLETION OF A SCAR (SUPPLIER CORRECTIVE ACTION REQUEST). UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. ((B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE JULY 2017 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE XCELA PORTS PRODUCT FAMILY AND THE FAILURE MODE "LEAKAGE." NO ADVERSE TREND WAS IDENTIFIED. AS THE REPORTED CATHETER IS A PURCHASED DEVICE FOR ANGIODYNAMICS, IT WAS FORWARDED TO OUR SUPPLIER, PFM MEDICAL, ALONG WITH A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR). THEIR RESPONSE INDICATED THAT AS RECEIVED, THE CATHETER TUBING WA ATTACHED TO THE PORT. THE CATHETER WAS NOTED TO BE DEFORMED ON A 1CM SECTION LOCATED 7.5CM FROM THE TIP. A 5MM SLIT ON THE CATHETER INDICATED THAT THE CATHETER HAD BEEN CLAMPLED AND UNCLAMPED MANY TIMES. FROM THE AMOUNT OF PUNCTURE MARKS ON THE SEPTUM THE PORT HAD LIKELY BEEN IMPLANTED FOR SEVERAL MONTHS. BASED ON THE ESTIMATED TIME OF IMPLANTATION, AND THE CONDITION OF THE RETURNED DEVICE, THE LEAKAGE WAS CAUSED BY THE SLIT IN THE CATHETER WHICH IS CONSISTENT WITH "PINCH-OFF. " THE DIRECTIONS FOR USE SUPPLIED WITH THE DEVICE INSTRUCTS THE PHYSICIAN/CLINICIAN ON HOW TO PROPERLY IMPLANT THE CATHETER/PORT, AND CAUTIONS AGAINST CERTAIN HANDLING TECHNIQUES TO AVOID "PINCH-OFF SYNDROME," A POTENTIAL COMPLICATION. (B)(4)

    Description of Event or Problem · 1

    EVENT CALLED IN BY THE MOTHER OF THE PATIENT. AN XCELA POWER INJECTABLE PORT WAS REMOVED ON (B)(6) 2017. THE REPORTED DESCRIPTION OF THE EVENT WAS : " PORT LEAKED IN PATIENT - ACCESSED ON SIDE OF PORT ON ((B)(6) AND PATIENT IMMEDIATELY BRUISED." THE PORT WAS REMOVED AT CHILDREN'S HOSPITAL OF ORANGE COUNTY AND THEY HAVE RETURNED THE DEVICE TO ANGIODYNAMICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561067 ANGIODYNAMICS / XCELA PORT & CATHETER IMPLANTED LJT PFM MEDICAL 135308000 H965451810

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR