BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY CATHETER

    MDR report key: 15414098 · Received September 13, 2022

    Report

    Report Number
    1220948-2022-00096
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 10, 2022
    Report Date
    September 13, 2022
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DXE
    UDI-DI
    00840663109869
    PMA / PMN Number
    K202049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED BEING CONFUSED ABOUT THE SIZE OF THE CATHETER FOR THE SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY CATHETER PRODUCT LINE. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT USES ONLY ONE CATHETER FRENCH SIZE, BUT DIFFERENT SIZE BALLOONS. ALTHOUGH THE OUTER DIAMETER SYMBOL SHOULD INDICATE 5F FOR ALL MODELS, OUR PRODUCT LABELS LIST THEM AS 3F-7F (THE CORRESPONDING SIZE WHICH EACH REPLACES BASED ON BALLOON SIZE.) IT WAS THOUGHT THAT HAVING DIFFERENT FRENCH SIZES LISTED WOULD BE HELPFUL FOR OPERATING ROOM STAFF FOR CHOOSING THE CATHETER NEEDED FOR THE OPERATION. IT WAS DETERMINED THAT ALL DEVICES WITH PYT LOT PREFIXES FOR CATALOG #S A4E01, A4E02, A4E03, A4E04, A4E08 AND A4E09 ARE AFFECTED BY THIS ISSUE. THIS IS THE ONLY COMPLAINT RELATED TO THE REPORTED ISSUE. NO ADVERSE REACTIONS HAVE BEEN REPORTED RELATED TO THIS PROBLEM. THIS IS IDENTIFIED AS A LABELING ISSUE THAT DOES NOT PUT THE PATIENT AT RISK. THE IFU CAUTIONS THE USER NOT TO EXCEED THE MAXIMUM INFLATED VOLUME CAPACITY. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    AN EMAIL WAS RECIEVED FROM A CUSTOMER ASKING WHY THEY RECEIVED A 3F SYNTEL OTW EMBOLECTOMY CATHETER WHEN THEY HAD ORDERED A 5F. IN DIGGING INTO THIS WE UNCOVERED THAT WHILE THE IFU LISTS ALL OF THE CATHETERS AS 5F DIAMETER, OUR PRODUCT LABELS LIST THEM AS 3F-7F (THE CORRESPONDING SIZE WHICH EACH REPLACES BASED ON BALLOON SIZE). THIS IS IDENTIFIED AS A LABELING ISSUE THAT IS NOT LIKELY TO CAUSE ADVERSE HEALTH CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390844 SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE LEMAITRE VASCULAR, INC. A4E01 SEE SECTION H10 00840663109869

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown