BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM XL ERCP CANNULA

    MDR report key: 279334 · Received May 26, 2000

    Report

    Report Number
    6000048-2000-00023
    Event Type
    Injury
    Date Received
    May 26, 2000
    Date of Event
    March 1, 2000
    Report Date
    May 25, 2000
    Manufacturer
    MICROVASIVE ENDOSCOPY, A DIV OF BOSTON SCIENTIFIC CORP.
    Product Code
    FGY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ERCP PROCEDURE, A PIECE OF THE TIP OF THE DEVICE WAS NOTICED TO HAVE BROKEN OFF AND MIGRATED TO THE COMMON BILE DUCT. THE PRODUCT WAS RETURNED FOR EVALUATION. A VISUAL EVALUATION REVEALED THAT A VERY SMALL PIECE OF THE DISTAL TIP OF THE CATHETER WAS MISSING. IT APPEARS THAT THE TIP OF THE CATHETER HAS BEEN SCRAPED AGAINST SOMETHING SHARP TO CAUSE THE SMALL PIECE TO DETACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEM XL ERCP CANNULA ERCP CANNULA FGY MICROVASIVE ENDOSCOPY, A DIV OF BOSTON SCIENTIFIC CORP. NA 2853636

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention