BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHLETIS PTA BALLOON DILATATION CATHETER

    MDR report key: 17054359 · Received June 2, 2023

    Report

    Report Number
    2124215-2023-25787
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 15, 2023
    Report Date
    August 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729974215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRO CODE (PRODUCT CODE): DQY. DEVICE EVALUATED BY MFR.: ATHLETIS DEVICE WAS RECEIVED 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 AT THE DISTAL MARKER BAND. AS PER ATHLETIS SPECIFICATION THE RATED BURST PRESSURE FOR THIS DEVICE IS 30 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 MARKER BANDS WERE UNDAMAGED AND PRESENT ON THE SHAFT OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    PRO CODE (PRODUCT CODE): DQY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN RADIAL ARTERY. A 10.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 25 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN RADIAL ARTERY. A 10.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 25 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089232 ATHLETIS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 39347-100470 0030457742 08714729974215

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female