BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHLETIS PTA BALLOON DILATATION CATHETER

    MDR report key: 19360982 · Received May 21, 2024

    Report

    Report Number
    2124215-2024-30824
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 30, 2024
    Report Date
    July 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729974260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE): LIT, DQY. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RECEIVED FOR PRODUCT ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE DEVICE WAS SUBJECTED TO POSITIVE PRESSURE. A LEAK TEST IDENTIFIED A BALLOON PINHOLE LOCATED APPROXIMATELY 20MM PROXIMAL OF THE TIP. 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. THIS CONCLUDES THE PRODUCT ANALYSIS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 12.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST BEFORE REACHING THE RATE BURST PRESSURE. THERE WERE NO COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 12.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST BEFORE REACHING THE RATE BURST PRESSURE. THERE WERE NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502576 ATHLETIS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 39347-120470 0030474683 08714729974260

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male