BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHLETIS PTA BALLOON DILATATION CATHETER

    MDR report key: 19353979 · Received May 20, 2024

    Report

    Report Number
    2124215-2024-30174
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 30, 2024
    Report Date
    June 20, 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.

    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 12.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, BEFORE THE BALLOON REACHED MEDIUM PRESSURE, IT RUPTURED. THE DEVICE WAS TAKEN OUT AND THE PATIENT WAS RE-TREATED FOR ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ABNORMALITIES OR PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, BEFORE THE BALLOON REACHED MEDIUM PRESSURE, IT RUPTURED. THE DEVICE WAS TAKEN OUT AND THE PATIENT WAS RE-TREATED FOR ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ABNORMALITIES OR PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED AND WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CEPHALIC VEIN. THE BALLOON RUPTURED AT 12 ATMOSPHERES FOR 30 SECONDS. THE PATIENT'S CURRENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788466 ATHLETIS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 39347-120470 0029389743 08714729974260

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male