BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHLETIS PTA BALLOON DILATATION CATHETER

    MDR report key: 16739881 · Received April 13, 2023

    Report

    Report Number
    2124215-2023-17584
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    April 10, 2023
    Report Date
    April 28, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729973799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): LIT, DQY. B5 - UPDATED DESCRIBE EVENT OR PROBLEM.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULA. A 6.0MM X 40MM X 75CM ATHLETIS BALLOON DILATATION CATHETER WAS ADVANCED. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST INSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 100% STENOSED AND WAS MILDLY TORTUOUS AND SEVERELY CALCIFIED. THE BALLOON WAS INFLATED TWICE BEFORE IT RUPTURED AND NO FRAGMENTS WERE LEFT INSIDE THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULA. A 6.0MM X 40MM X 75CM ATHLETIS BALLOON DILATATION CATHETER WAS ADVANCED. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST INSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027019 ATHLETIS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 39347-060470 0029429567 08714729973799

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male