BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTEL SILICONE THROMBECTOMY CATHETER

    MDR report key: 19059191 · Received April 8, 2024

    Report

    Report Number
    1220948-2024-00100
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    April 5, 2024
    Report Date
    April 8, 2024
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DXE
    PMA / PMN Number
    K910372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF OUR ANALYSIS OF DATA REVIEW DURING A MANAGEMENT REVIEW MEETING A TREND WAS IDENTIFIED FOR THESE COMPLAINTS, AND IT WAS DETERMINED TO ISSUE CAPA 2023-028. DURING OUR INITIAL FAILURE INVESTIGATION, A POTENTIAL CAUSE WAS IDENTIFIED FOR HIGH VARIATION IN THE PROCESS DUE TO ITS MANUAL PROCESSING NATURE AND UNCLEAR MANUFACTURING INSTRUCTIONS. FURTHER TESTING (E.G., DOE) DETERMINED THAT SOME DEVICES FAILED TO MEET OUR PULL TEST SPECIFICATION. NO ADDITIONAL COMPLAINTS FOR THIS ISSUE HAVE BEEN RECEIVED SINCE AUGUST 2023, CONFIRMING THE REMOTE OCCURRENCE. HOWEVER, IF THE ISSUE OCCURS IT MAY CAUSE TEMPORARILY OR MEDICALLY REVERSIBLE HEALTH CONSEQUENCES, WHERE THE PROBABILITY OF SERIOUS ADVERSE HEALTH CONSEQUENCES IS REMOTE; THEREFORE, WE HAVE DETERMINED THAT THE PRODUCT IS VIOLATIVE AND WE CONCLUDE THAT REGULATORY ACTION IS REQUIRED IN THE FORM OF A CLASS II RECALL.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT DURING THE USE OF THE SYNTEL SILICONE THROMBECTOMY CATHETER, THE GUIDE TIP (NOT THE BALLOON OR CATHETER) CAN BECOME DAMAGED AND RESULT IN TIP DETACHING. THE RISK OF THIS ISSUE IS THAT THE DISTAL TIP OF THE CATHETER SEPARATES WHILE IN USE IN THE PATIENT AND REQUIRES ADDITIONAL MEDICAL INTERVENTION TO PREVENT INJURY. FOUR COMPLAINTS HAVE BEEN REPORTED FOR THIS ISSUE INCLUDING A TOTAL OF SEVEN DEVICES OF THE SAME CATALOG # A4545 (SYNTEL THROMBECTOMY CATHETER, 4F, 50CM) FROM THREE DIFFERENT LOTS: SST1030, SST1032, AND SST1036. COMPLAINTS FROM ONE CUSTOMER, PUERTO RICO VASCULAR ACCESS CENTER, INCLUDED SIX OF THE SEVEN DEVICES FROM THE 3 LOTS ABOVE; AND LIFELINE VASCULAR / SOUTHWEST ACCESS CENTER (ILLINOIS) COMPLAINT INCLUDED THE SEVENTH DEVICE FROM LOT SST1032. NO INJURIES HAVE OCCURRED AS A RESULT OF THIS ISSUE. NO ADDITIONAL COMPLAINTS FOR THIS ISSUE HAVE BEEN RECEIVED SINCE AUGUST 2023, CONFIRMING THE REMOTE OCCURRENCE. HOWEVER, IF THE ISSUE OCCURS IT MAY CAUSE TEMPORARILY OR MEDICALLY REVERSIBLE HEALTH CONSEQUENCES, WHERE THE PROBABILITY OF SERIOUS ADVERSE HEALTH CONSEQUENCES IS REMOTE; THEREFORE, WE HAVE DETERMINED THAT THE PRODUCT IS VIOLATIVE AND WE CONCLUDE THAT REGULATORY ACTION IS REQUIRED IN THE FORM OF A CLASS II RECALL. PLEASE NOTE: PRIOR EMDR SUBMISSIONS HAVE BEEN MADE FOR EACH OF THE REPORTED FAILURES (SEE H10, RELATED REPORT NUMBERS SECTION FOR REPORT NUMBERS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412592 SYNTEL SILICONE THROMBECTOMY CATHETER THROMBECTOMY CATHETER DXE LEMAITRE VASCULAR, INC. SSTXXXX LOT NUMBERS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown