BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR PRO XL

    MDR report key: 17283658 · Received July 7, 2023

    Report

    Report Number
    3005099803-2023-03628
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729790648
    PMA / PMN Number
    K102082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF TIP BENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE DISTAL COMMON BILE DUCT FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158743 EXTRACTOR PRO XL CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00547120 0030735885 08714729790648

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown