BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHLETIS PTA BALLOON DILATATION CATHETER

    MDR report key: 17665232 · Received August 31, 2023

    Report

    Report Number
    2124215-2023-44755
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 11, 2023
    Report Date
    October 31, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729974215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE) - LIT, DQY THE FOLLOWING D4S WERE UPDATED: D4: MODEL NUMBER - 39347-100470, LOT NUMBER - 30153169, CATALOG NUMBER - 39347-100470, EXPIRATION DATE - 09/14/2025, UNIQUE IDENTIFIER (UDI) # (B)(4). DEVICE EVALUATED BY MFR.: AN ATHLETIS DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. THE RATED BURST PRESSURE FOR THIS DEVICE IS 30 ATMOSPHERES. THE RETURNED DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND POSITIVE PRESSURE WAS APPLIED WHEN LIQUID WAS OBSERVED TO BE LEAKING FROM A BALLOON PINHOLE LOCATED APPROXIMATELY 25MM DISTAL FROM THE PROXIMAL MARKERBAND. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO KINKS OR DAMAGE TO THE SHAFT AND NO DAMAGED ON THE TIP IDENTIFIED VISUALLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. DURING THE PROCEDURE, A 10 MM X 40 MM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, BEFORE REACHING THE RATED BURST PRESSURE, THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THERE WERE NO FURTHER INFORMATION WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. DURING THE PROCEDURE, A 10 MM X 40 MM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, BEFORE REACHING THE RATED BURST PRESSURE, THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THERE WERE NO FURTHER INFORMATION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437684 ATHLETIS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 39347-100470 0030153169 08714729974215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown