BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEK OTW

    MDR report key: 3904180 · Received May 26, 2014

    Report

    Report Number
    9616666-2014-00005
    Event Type
    Injury
    Date Received
    May 26, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE RECEIPT IS PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO DEFLATE. THE TARGET LESION WAS THE ANTERIOR TIBIAL ARTERY. THE PHYSICIAN STRUGGLED TO ADVANCE THE DEVICE TO THE INFLATION LOCATION. WHEN THE DEVICE WAS INFLATED IT JUMPED TO 12ATM. THE DEVICE WAS THEN DEFLATED. A SECOND ATTEMPT WAS MADE TO DEFLATE THE DEVICE. AGAIN THE ATM GAUGE JUMPED TO 12 AND THE BALLOON MOVED DOWN THE VESSEL AND THE GAUGE DROPPED TO 6ATM. THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON HOWEVER, THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN HAD TO NUMB THE PATIENTS LOWER LEG AND UNDER FLUORO-GUIDANCE STUCK A 21 GAUGE NEEDLE PERCUTANEOUS TO RUPTURE THE BALLOON. THE DEVICE WAS REMOVED FROM THE PATIENT. AN ANGIOGRAM SHOULD IMPROVED FLOW DOWN THE TIBIAL ARTERY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310051 SLEEK OTW LIT CLEAR STREAM TECHNOLOGIES, LTD. 50054198

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention