BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS / VORTEX

    MDR report key: 6913281 · Received October 4, 2017

    Report

    Report Number
    1317056-2017-00080
    Event Type
    Injury
    Date Received
    October 4, 2017
    Date of Event
    August 1, 2017
    Report Date
    October 27, 2017
    Manufacturer
    PFM MEDICAL
    Product Code
    LJT
    UDI-DI
    H965451840
    PMA / PMN Number
    K071993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANGIODYNAMICS IS IN THE PROCESS OF FINDING OUT WHETHER THE DEVICE SAMPLE WILL BE RETURNED. AS THIS PORT IS A PURCHASED COMPONENT, THE MANUFACTURER, PFM MEDICAL HAS BEEN MADE AWARE OF THE EVENT AND WILL BE RESPONDING VIA A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR). THE SAMPLE, IF IT BECOMES AVAILABLE, WILL BE FORWARDED TO PFM FOR EVALUATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING LOT (130823 000) FOR ITEM NUMBER H965451840 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 RCENT ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE XCELA PORTS {PFM} PRODUCT FAMILY AND THE FAILURE MODE "CATHETER DETACHED/MIGRATED. " NO ADVERSE TREND WAS IDENTIFIED. ALTHOUGH THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION, ANGIODYNAMICS NOTIFIED THE PORT SUPPLIER/MANUFACTURER, PFM MEDICAL OF THE EVENT VIA A SUPPLIER CORRECTIVE ACTION REPORT (SCAR). PFM PERFORMED A DEVICE HISTORY RECORDS REVIEW AND VERIFIED THAT THERE WERE NO QUALITY OR MANUFACTURING NON-CONFORMANCES NOTED FOR THIS LOT. WITHOUT A SAMPLE ANALYSIS, THE EXACT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY HOSPITAL ON USER MEDWATCH # (B)(4): "EVENT DESCRIPTION: DURING PORT REMOVAL PROCEDURE IT WAS NOTED TUBING WAS NOT CONNECTED TO THE PORT - NO EVIDENCE OF TUBING IN CANAL OR IN NECK AREA. X-RAY REVEALED TUBING LOCATED IN RIGHT VENTRICLE. PATIENT REQUIRED ADDITIONAL PROCEDURE TO RETRIEVE TUBING. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? - PORT REMOVAL." FURTHER INFORMATION RECEIVED FROM THE HOSPITAL INDICATED THAT THE PORT HAD NOT BEEN ACCESSED AT THE HOSPITAL SINCE (B)(6) 2017. THE PATIENT REPORTED THAT IT HAD BEEN "ACCESSED LOCALLY IN (B)(6) 2017 WITHOUT ISSUE." THE PORT WAS BEING REMOVED BECAUSE OF END-OF-TREATMENT. IT HAS NOT BEEN CONFIRMED YET AS TO WHETHER THE DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693346 ANGIODYNAMICS / VORTEX PORT & CATHETER IMPLANTED LJT PFM MEDICAL 130823000 H965451840

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention