BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHLETIS PTA BALLOON DILATATION CATHETER

    MDR report key: 16303387 · Received February 6, 2023

    Report

    Report Number
    2124215-2023-03823
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    January 1, 2023
    Report Date
    March 8, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729973911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: USED THE FIRST DAY OF THE MONTH OF THE BSC AWARE DATE SINCE EVENT DATE WAS NOT PROVIDED. PRO CODE (PRODUCT CODE): DQY.

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: USED THE FIRST DAY OF THE MONTH OF THE BSC AWARE DATE SINCE EVENT DATE WAS NOT PROVIDED. D2B PRO CODE (PRODUCT CODE): DQY DEVICE EVALUATED BY MFR.: RECEIVED ATHLETIS DEVICE FOR ANALYSIS. THE INVESTIGATOR OPENED THE PACKAGING FULLY AND REMOVED THE DEVICE. NO FOREIGN MATERIAL WAS NOTED ON THE DEVICE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED MULTIPLE SHAFT KINKS ALONG THE LENGTH OF THE SHAFT. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO DAMAGE TO THE TIP WHICH MAY HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT ON THE DEVICE. A 7.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS BROUGHT TO BIOHAZARD ROOM FOR ANALYSIS AS FOREIGN MATTER WAS OBSERVED PRESENT WITH THE DEVICE. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT ON THE DEVICE. A 7.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS BROUGHT TO BIOHAZARD ROOM FOR ANALYSIS AS FOREIGN MATTER WAS OBSERVED PRESENT WITH THE DEVICE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494803 ATHLETIS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 39347-070470 0030355781 08714729973911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown