BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 20524402 · Received October 24, 2024

    Report

    Report Number
    3008737795-2024-00011
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    September 26, 2022
    Report Date
    October 24, 2024
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW, CONFIRMING THAT THE PRODUCT SOLD TO THIS FACILITY MET ITS SPECIFICATIONS. HOWEVER, WITHOUT A RETURNED PRODUCT FOR TECHNICAL INVESTIGATION, PFM MEDICAL CPP COULD NOT CONFIRM THE REPORTED DEFECT OF "INFECTION." THE RELATED RISKS ARE DOCUMENTED IN OUR RISK MANAGEMENT FILE. AS A RESULT, THE COMPLAINT IS CLASSIFIED AS "NO DEFINITIVE CONCLUSION, UNVERIFIABLE" DUE TO THE ABSENCE OF THE RETURNED PRODUCT. FOR OPTIMAL COMPLAINT MANAGEMENT, THE RETURN OF THE PRODUCT IN QUESTION IS ESSENTIAL FOR A COMPLETE INVESTIGATION, PARTICULARLY IF CONTAMINATION IS SUSPECTED. ITEM NUMBER ITEM DESCRIPTION LOT NUMBER EXPIRATION DATE UDI H965451030 XCELA STD/T/8.0/SL/F/A 137399 000 06/30/2021 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 135904 000 06/30/2020 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 135900 000 06/30/2020 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 135896 000 06/30/2020 (B)(4); H965451090 XCELA LOW PROFILE/T/6.6/SL/F/A 135312 000 12/31/2019 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 135081 000 12/31/2019 (B)(4); H965451090 XCELA LOW PROFILE/T/6.6/SL/F/A 134827 000 12/31/2019 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 134756 000 12/31/2019 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 134753 000 12/31/2019 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 133535 000 06/30/2019 (B)(4); H965451090 XCELA LOW PROFILE/T/6.6/SL/F/A 133471 000 06/30/2019 (B)(4); H965451090 XCELA LOW PROFILE/T/6.6/SL/F/A 133473 000 06/30/2019 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 133421 000 06/30/2019 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 132877 000 06/30/2019 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 132877 000 06/30/2019 (B)(4); H965451090 XCELA LOW PROFILE/T/6.6/SL/F/A 132480 000 12/31/2018 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 132470 000 12/31/2018 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 132295 000 12/31/2018 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 132291 000 12/31/2018 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 132291 000 12/31/2018 (B)(4); H965451090 XCELA LOW PROFILE/T/6.6/SL/F/A 131899 000 12/31/2018 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 130647 000 12/31/2017 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 130646 000 12/31/2017 (B)(4); H965451090 XCELA LOW PROFILE/T/6.6/SL/F/A 130332 000 12/31/2017 (B)(4); H965451030 XCELA STD/T/8.0/SL/F/A 130506 000 12/31/2017 (B)(4); H965451090 XCELA LOW PROFILE/T/6.6/SL/F/A 120713 000 12/31/2016 (B)(4); H965451090 XCELA LOW PROFILE/T/6.6/SL/F/A 120905 000 12/31/2016 (B)(4); H965451090 XCELA LOW PROFILE/T/6.6/SL/F/A 120906 000 06/30/2017 (B)(4); H965451090 XCELA LOW PROFILE/T/6.6/SL/F/A 121470 000 06/30/2017 (B)(4).

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2016, PATIENT UNDERWENT PLACEMENT OF THE ANGIODYNAMICS XCELA. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) MEDICAL CENTER IN (B)(6) FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2022, PATIENT PRESENTED TO (B)(6) MEDICAL CENTER AFTER BLOOD CULTURES, DRAWN ON (B)(6) 2022, TESTED POSITIVE. UPON ADMISSION, PATIENT'S BLOOD CULTURES WERE REDRAWN AND REMAINED POSITIVE. ON OR ABOUT (B)(6) 2022, PATIENT'S DEVICE WAS REMOVED BY DR. (B)(6), M.D. AT (B)(6) MEDICAL CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579648 XCELA XCELA POWER INJECTABLE PORT LJT PFM MEDICAL CPP SA UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention