BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHLETIS PTA BALLOON DILATATION CATHETER

    MDR report key: 15179799 · Received August 5, 2022

    Report

    Report Number
    2134265-2022-08287
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    July 12, 2022
    Report Date
    August 5, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K201170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE: LIT, DQY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. AN ATHLETIS PTA BALLOON DILATATION CATHETER WAS SELECTED FOR THE INDEX GI TUBE PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE BALLOON WAS ABLE TO BE REMOVED SUCCESSFULLY FROM THE PATIENT, AND A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689126 ATHLETIS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown