BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010

    MDR report key: 1934126 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05321
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE STENT HAS BEEN IMPLANTED; HOWEVER THE DELIVERY SYSTEM IS AVAILABLE FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS USED DURING A DUODENAL STENTING PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT THE PATIENT HAD A DUODENAL OBSTRUCTION; HOWEVER THE ANATOMY WAS NOT PARTICULARLY TORTUOUS. THE ENDOSCOPE WAS INSERTED INTO THE PATIENT, AND THEN THE STENT DELIVERY WAS ADVANCED OVER THE GUIDE WIRE AND PAST THE DUODENAL OBSTRUCTION. DURING DEPLOYMENT, THE DEPLOYMENT HANDLE SNAPPED. THE NURSE MANIPULATED THE CATHETER AND WAS ABLE TO DEPLOY THE STENT IN A SATISFACTORY POSITION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010 STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565030 13786426

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE| GUIDE WIRE