BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX BILIARY

    MDR report key: 3111447 · Received May 14, 2013

    Report

    Report Number
    3005099803-2013-03809
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REPORTED TO BE IN HIS (B)(6). (B)(4). THE DEVICE HAS NOT BEEN RECEIVED 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 FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE GASTROBILIARY PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN DEPLOYING THE STENT INSIDE THE PATIENT, THE GUIDE CATHETER BROKE AND THE BROKEN PORTION REMAINED INSIDE THE STENT. THE STENT AND BROKEN PIECE OF THE CATHETER WERE SUCCESSFULLY RETRIEVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213388 RX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00545560 15494178

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention