BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM

    MDR report key: 1881219 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04528
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K073266
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED TO BE OVER 18 YEARS OF AGE.(B)(4) - NON-SURGICAL INTERVENTION REQUIRED.(B)(4) STENT POSITIONING ISSUE.(B)(4) CATHETER DELIVERY SYSTEM MISSING RADIO-OPAQUE MARKER.THE STENT DELIVERY SYSTEM WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS USED DURING AN EGD PROCEDURE WITHIN THE ESOPHAGUS ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE DISTAL RADIO-OPAQUE FLUORO MARKER WAS NOT ON THE CATHETER, WHICH CAUSED HIM TO MISDEPLOY THE STENT. THE PHYSICIAN NEEDED TO USE ANOTHER STENT TO BRIDGE THE DISTAL END OF THE STRICTURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516940 13556324

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention