BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER

    MDR report key: 18493757 · Received January 11, 2024

    Report

    Report Number
    1220948-2024-00015
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 11, 2023
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DXE
    UDI-DI
    00840663100750
    PMA / PMN Number
    K022145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION. HOWEVER, THE PROVIDED PHOTO CONFIRMED THE REPORT. IT SHOWS THE BALLOON RUPTURED. WHILE THE REPORTED EVENT WAS CONFIRMED, THE EXACT ROOT CAUSE OF THE BALLOON RUPTURE COULD NOT BE DETERMINED. DUE TO THE NATURE OF THE PRODUCT, BALLOON RUPTURES ARE AN EXPECTED RISK WHEN USING THIS PRODUCT. AS STATED IN THE IFU: AS WITH ALL CATHETERIZATION PROCEDURES, COMPLICATIONS MAY OCCUR. THESE MAY INCLUDE BUT ARE NOT LIMITED TO: INFECTION, LOCAL HEMATOMAS, INTIMAL DISRUPTION, ARTERIAL DISSECTION, PERFORATION AND RUPTURE, HEMORRHAGE, ARTERIAL THROMBOSIS, DISTAL EMBOLI OF BLOOD CLOTS OR ARTERIOSCLEROTIC PLAQUE, AIR EMBOLUS, ANEURYSMS, ARTERIAL SPASMS, ARTERIOVENOUS FISTULA FORMATION, BALLOON RUPTURE OR TIP SEPARATION WITH FRAGMENTATION AND DISTAL EMBOLIZATION. THE POSSIBILITY OF BALLOON RUPTURE MUST BE TAKEN INTO ACCOUNT WHEN CONSIDERING THE RISKS INVOLVED IN THE CATHERIZATION PROCEDURE. OUR REVIEW OF THE LOT HISTORY RECORD FOR THESE LOTS DID NOT FIND ANY DISCREPANCIES EITHER IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS INCIDENT. CAPA 2021-009 WAS PREVIOUSLY OPENED TO ADDRESS THIS ISSUE. NO FURTHER ACTION NEEDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUFTTEX OTW BALLOON RUPTURED DURING A PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667092 TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER OVER-THE-WIRE EMBOLECTOMY CATHETER DXE LEMAITRE VASCULAR, INC. XOT1317 00840663100750

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown