BEUDAMED
    FDA Adverse Event Other Summary report: N

    SLEEK OTW

    MDR report key: 2396658 · Received December 5, 2011

    Report

    Report Number
    9616666-2011-00016
    Event Type
    Other
    Date Received
    December 5, 2011
    Date of Event
    November 21, 2011
    Report Date
    February 12, 2011
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K102035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS POST DILATING WITHIN A STENT HE HAD JUST DEPLOYED IN THE RIGHT SFA WITH A SLEEK OTW 5 X 120. HE DID A POST DIL IN THE DISTAL PART OF THE STENT/SFA FIRST AND THAT WENT WELL, BUT THEN HE DID A POST DIL IN THE PROXIMAL PORTION OF THE STENT/SFA AND THE BALLOON WOULD NOT DISINFLATE. IN ORDER FOR THE BALLOON TO DISINFLATE, THE DOCTOR HAD TO PUNCTURE IT WITH A MICROPUNCTURE NEEDLE THROUGH THE GROIN USING ULTRASOUND AND THEN HE WAS ABLE TO PULL THE BALLOON THROUGH THE SHEATH AND OUT OF THE PATIENT'S BODY. THE PROCEDURE WAS A SUCCESS ALTHOUGH THE BALLOON DID NOT DISINFLATE, IT HAD DONE ITS JOB AND THE DOCTOR HAD COMPLETED THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK OTW PTA CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50030884

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention