BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCLUDER

    MDR report key: 12045715 · Received June 22, 2021

    Report

    Report Number
    3005099803-2021-03021
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    April 12, 2021
    Report Date
    June 22, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EYB
    UDI-DI
    08714729161691
    PMA / PMN Number
    K133750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE FOUND THAT THE BALLOON, DISTAL TIP AND HUB WERE IN A GOOD CONDITION. THERE WERE NO KINKS, CLAMP MARKS OR ELONGATION NOTED ON THE BALLOON. FUNCTIONAL EVALUATION WAS PERFORMED, AND THE BALLOON WAS INFLATED; HOWEVER, IT WAS NOTICED THAT THE BALLOON HAD A PINHOLE. THE FOUND FAILURE OF A PINHOLE CONFIRMS THE REPORTED EVENT OF THE BALLOON LEAKING. THIS FAILURE IS LIKELY THAT THE PINHOLE IS THE RESULT OF DEVICE MANIPULATION WHILE THE DEVICE HAD BEEN PREPARED OR AN EXTRA FORCE COULD HAVE BEEN APPLIED ON IT CAUSING THE PINHOLE AND CONSEQUENTLY THE LEAK THAT WAS BEING REPORTED. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE TO BE USED IN THE URETER/KIDNEY PERFORMED ON (B)(6) 2021. DURING PREPARATION, THE BALLOON WAS NOTED TO BE LEAKING WHILE THE CONTRAST WITH NACL WAS BEING INSERTED WITHOUT INFLATING THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THIS BALLOON HAS A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937101 OCCLUDER CATHETER, UROLOGICAL EYB BOSTON SCIENTIFIC CORPORATION M0062201100 0026206686 08714729161691

    Patients

    Seq Age Sex Outcome Treatment
    1