BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHLETIS PTA BALLOON DILATATION CATHETER

    MDR report key: 13600923 · Received February 25, 2022

    Report

    Report Number
    2134265-2022-01858
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    February 2, 2022
    Report Date
    February 25, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729974093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRO CODE: LIT, DQY.

    Additional Manufacturer Narrative · 0

    PRO CODE: LIT, DQY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AN 8.0MM X 80MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS SELECTED FOR AN ARTERIOVENOUS GRAFT (AVG) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE TARGET LESION WAS 80% STENOSED. DURING THE FIRST INFLATION OF LESS THAN 10 SECONDS, THE BALLOON RUPTURED. AFTER DECOMPRESSION, THE DEVICE WAS ABLE TO BE REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AN 8.0MM X 80MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS SELECTED FOR AN ARTERIOVENOUS GRAFT (AVG) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE TARGET LESION WAS 80% STENOSED. DURING THE FIRST INFLATION OF LESS THAN 10 SECONDS, THE BALLOON RUPTURED. AFTER DECOMPRESSION, THE DEVICE WAS ABLE TO BE REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2436325 ATHLETIS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 39347-080870 0026786566 08714729974093

    Patients

    Seq Age Sex Outcome Treatment
    1 Female