BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHLETIS PTA BALLOON DILATATION CATHETER

    MDR report key: 18175821 · Received November 20, 2023

    Report

    Report Number
    2124215-2023-65459
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    November 8, 2023
    Report Date
    January 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729974055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2 - REPORT SOURCE: CORRECTED TO 'COMPANY REPRESENTATIVE, HEALTH PROFESSIONAL, USER FACILITY, AND DISTRIBUTOR/IMPORTER.' D2B - PRO CODE (PRODUCT CODE): LIT, DQY. DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE DEVICE WAS SUBJECTED TO POSITIVE PRESSURE. A BALLOON PINHOLE WAS IDENTIFIED LOCATED APPROXIMATELY 8MM PROXIMAL OF THE DISTAL MARKERBAND. A VISUAL EXAMINATION OBSERVED NO DAMAGE TO THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION FOUND NO KINKS OR DAMAGE TO THE SHAFT OF THE DEVICE. BOTH MARKERBANDS WERE UNDAMAGED AND PRESENT ON THE SHAFT OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): LIT, DQY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON EXPLODED UPON INFLATION AT 26 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 8.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON EXPLODED UPON INFLATION AT 26 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021778 ATHLETIS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 39347-080470 0031944093 08714729974055

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male