BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHLETIS PTA BALLOON DILATATION CATHETER

    MDR report key: 18895949 · Received March 13, 2024

    Report

    Report Number
    2124215-2024-12096
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    February 19, 2024
    Report Date
    April 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729974222
    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. THE RETURNED DEVICE WAS ATTACHED TO AN INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN LIQUID WAS OBSERVED TO BE LEAKING FROM A BALLOON PINHOLE LOCATED APPROXIMATELY 27MM PROXIMAL OF THE DISTAL MARKERBAND. AS PER SPECIFICATION, THE RATED BURST PRESSURE FOR THIS DEVICE IS 27 ATMOSPHERES. 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 A BALLOON BURST OCCURRED. A 10.0MM X 80MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON BURST JUST BEFORE THE WORKING PRESSURE WAS REACHED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON BURST OCCURRED. A 10.0MM X 80MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON BURST JUST BEFORE THE WORKING PRESSURE WAS REACHED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027177 ATHLETIS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 39347-100870 0029768595 08714729974222

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown