BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT? BILIARY

    MDR report key: 3181659 · Received June 21, 2013

    Report

    Report Number
    3005099803-2013-05409
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K000308
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 WALLSTENT BILIARY WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING PLACED FOR THE TREATMENT OF BILIARY STRICTURE. THE STRICTURE WAS 2-3 CM IN SIZE AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE DOCTOR ATTEMPTED TO DEPLOY THE STENT AND THE STENT WOULD NOT DEPLOY. THE DOCTOR ATTEMPTED TO DEPLOY THE STENT AGAIN AND THE STENT WOULD NOT DEPLOY, HOWEVER, AFTER 5-7 SECONDS THE STENT QUICKLY PREMATURELY DEPLOYED INTO THE WRONG LOCATION. THE STENT WAS LEFT IN IMPLANTED AND ANOTHER WALLSTENT BILIARY WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282078 WALLSTENT? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965431100 0014885242

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention