BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEK RX PTA CATHETER

    MDR report key: 3676768 · Received February 25, 2014

    Report

    Report Number
    9616666-2014-00002
    Event Type
    Injury
    Date Received
    February 25, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 31, 2014
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED BY THE CUSTOMER AND THE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON RUPTURED. THE TARGET LESION WAS THE ANTERIOR TIBIAL ARTERY. REPORTEDLY, THE LESION WAS MODERATELY CALCIFIED, NOT TORTUOUS AND THE RATE OF STENOSIS WAS 100% (CTO). THERE WAS DIFFICULTY ADVANCING THE GUIDEWIRE AND THE DEVICE TO THE LESION AND THE DEVICE FAILED TO CROSS THE LESION. A SECOND BALLOON CATHETER WAS INFLATED AT THE LESION. THE COMPLAINT DEVICE WAS IN-INSERTED INTO THE PT AND INFLATED AT THE LESION. THE PHYSICIAN ATTEMPTED TO MAINTAIN THE PRESSURE AT 6ATM, BUT THE BALLOON RUPTURED. THE DEVICE WAS EASILY REMOVED FROM THE LESION. A SLIGHT VESSEL DISSECTION WAS OBSERVED. THE DISSECTION DID NOT CAUSE THE VESSEL TO THROMBOSE AND THROMBOSIS WAS NOT OBSERVED PRIOR TO THE PROCEDURE. THE PHYSICIAN TREATED THE DISSECTION BY DILATATION OF A BALLOON CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ANOMALIES WERE NOTED DURING THE PREP OF THE DEVICE. THE PT IS IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116056 SLEEK RX PTA CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50056659

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention