BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASTIPP DISPOSABLE RESECTOR

    MDR report key: 16524608 · Received March 10, 2023

    Report

    Report Number
    1220948-2023-00037
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    February 10, 2023
    Report Date
    March 10, 2023
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DWQ
    UDI-DI
    00840663110179
    PMA / PMN Number
    K212894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION, THEREFORE THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED. IF THE SHEATH TEARS IT IS POSSIBLE FOR A NONSTERILE PORTION OF THE DEVICE TO BE EXPOSED TO THE STERILE FIELD. THE EXACT CAUSE OF THE TEAR IN THE MATERIAL IS NOT KNOWN. NO ADVERSE EVENT OCCURRED AS A RESULT OF THIS ISSUE. THE LOT HISTORY RECORD FOR THE DEVICE WAS REVIEWED, NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ADDITIONALLY, WE HAVE NOT RECEIVED ANY REPORTS OF SIMILAR ISSUES OCCURRING FOR THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHASTIPP DISPOSABLE RESECTOR SHEATH OF THE DISPOSABLE RESECTOR TORE DURING VARICOSE VEIN REMOVAL. THE TEAR WAS AT THE BACK END OF THE SHEATH AND STARTED WITH JUST A SMALL, INCONSEQUENTIAL TEAR DURING THE SHEATH DEPLOYMENT (AT THE BEGINNING OF CASE SETUP). DURING THE CASE THE END OF THE SHEATH/TUBING WERE CLAMPED TO THE STERILE DRAPES AND THE CLAMPS CAME LOOSE. THE BACK END OF THE DEVICE FELL DOWN AND CAUSED THE TEAR TO LENGTHEN IN SIZE CONSIDERABLY (FROM ABOUT 1" TO ABOUT 12"). AS A RESULT, THERE WAS A RISK OF NON-STERILE PRODUCT BEING IN THE SURGICAL AREA. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921926 PHASTIPP DISPOSABLE RESECTOR EXTERNAL VEIN STRIPPER DWQ LEMAITRE VASCULAR, INC. TIP0001PMS 00840663110179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown