BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERYX PROCEDURE KIT

    MDR report key: 1333202 · Received March 5, 2009

    Report

    Report Number
    3005099803-2008-01923
    Event Type
    Injury
    Date Received
    March 5, 2009
    Date of Event
    December 19, 2003
    Report Date
    August 5, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH
    Product Code
    LMN
    PMA / PMN Number
    P020006
    Removal / Correction Number
    Z-0040-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, A DEVICE EVALUATION CANNOT BE PERFORMED. NOTE: THIS PRODUCT WAS REMOVED FROM THE GLOBAL MARKET IN SEPTEMBER 2005. BOSTON SCIENTIFIC CORPORATION NO LONGER PRODUCES THE REPORTED PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 5, 2005 THAT AN ENTERYX PROCEDURE KIT WAS IMPLANTED IN A PATIENT IN LATE 2003 (PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN). SIX INJECTIONS WERE PERFORMED, DELIVERING A TOTAL OF 8.1CC'S OF ENTERYX SOLUTION TO THE PATIENT . OF THE TOTAL SOLUTION DELIVERED, 0.22CC'S WAS INJECTED SUBMUCOSALLY. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN ONSET OF CHEST PAIN OF SEVERE INTENSITY A WEEK LATER. THE CHEST PAIN WAS ASSOCIATED WITH COUGHING SPELLS SECONDARY TO A CONGENITAL TRACHEAL-ESOPHAGEAL FISTULA. IN 2005, THE FISTULA WAS REPAIRED SURGICALLY. THE SURGERY WAS SUCCESSFUL AND THE COUGHING SPELLS WHICH LED TO THE REPORTED CHEST PAIN HAVE DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERYX PROCEDURE KIT CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES LMN BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH M00572600 60903

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention