BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEP OTW PTA CATHETER

    MDR report key: 3750978 · Received February 18, 2014

    Report

    Report Number
    9616666-2014-00001
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 17, 2014
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K102035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY IN PROGRESS. THE DEVICE HAS NOT YET BEEN RETURNED BY THE CUSTOMER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON HAD SLOW DEFLATION. THE TARGET LESION WAS THE TIBIAL ARTERY. REPORTEDLY, THE VESSEL WAS TORTUOUS. THERE WAS NO DIFFICULTY ADVANCING THE GUIDEWIRE OR THE DEVICE TO THE TARGET LESION. THE BALLOON WAS INFLATED TWICE TO A MAXIMUM INFLATION PRESSURE OF 12 ATM. SLOW DEFLATION WAS OBSERVED AND A SYRINGE WAS REQUIRED TO DEFLATE THE BALLOON. A KINK WAS SUSPECTED ON THE SHAFT. THE DEVICE WAS EASILY REMOVED FORM THE PATIENT AND ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ANOMALIES WERE NOTED DURING THE PREP OF THE DEVICE. A 60-40 CONTRAST MEDIUM WAS USED. FORCE WAS NOT USED WHEN USING THE DEVICE AND IT WAS ONLY INSERTED INTO THE PATIENT ONCE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100877 SLEEP OTW PTA CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50052577

    Patients

    Seq Age Sex Outcome Treatment
    1