BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEC CUTTER CATHETER

    MDR report key: 248498 · Received November 4, 1999

    Report

    Report Number
    2024805-1999-00005
    Event Type
    Injury
    Date Received
    November 4, 1999
    Date of Event
    October 6, 1999
    Report Date
    November 2, 1999
    Manufacturer
    INTERVENTIONAL TECHNOLOGIES, INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT OCCURRED DURING A "TEC" PERIPHERAL PROCEDURE FOR A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN FELT RESISTANCE AND HAD DIFFICULTY ADVANCING THE CATHETER. IT WAS NOTED BY THE PHYSICIAN AND THE INTERVENTIONAL TECHNOLOGIES INC SALES REPRESENTATIVE THAT THE SHEATH WAS AT AN ACUTE ANGLE. THE ACUTE ANGLE OF THE ENTRY ARTERY PLACED AN ABNORMAL AMOUNT OF PRESSURE ON THE SHEATH AND THE CATHETER INSIDE. THE DRAG AGAINST THE SHEATH DURING ROTATION GENERATED FRICTION ON THE CATHETER AND SUBSEQUENTLY CAUSED THE CATHETER TO FRACTURE. THE PHYSICIAN STATED TO THE SALES REPRESENTATIVE THAT ALTHOUGH THE PT WAS STABLE HE WAS GOING TO PERFORM A FEM POP BYPASS. THE PHYSICIAN DID NOT CONDUCT AN ANGIOGRAM FOLLOW-UP, THEREFORE CO DOES NOT KNOW IF THE FRACTURE IN THE CATHETER NECESSITATED THE BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEC CUTTER CATHETER ATHERECTOMY CATHETER MCW INTERVENTIONAL TECHNOLOGIES, INC. P102370 F9914602

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention TEC INTRAOPERATIVE SYSTEM-POWER PACK,| TEC INTRAOPERATIVE SYSTEM- DRIVE UNIT.