BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX? BILIARY

    MDR report key: 3090492 · Received May 2, 2013

    Report

    Report Number
    3005099803-2013-03165
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT HAD BEEN FULLY DEPLOYED FROM THE DEVICE. THE STENT WAS NOT RETURNED. IT WAS NOTED THAT THE SHAFT WAS KINKED IN THE MID-SECTION OF THE GUIDEWIRE ACCESS SLEEVE. NO OTHER ISSUES WERE NOTED WITH THE PROFILE OF THE DEVICE. DURING ANALYSIS, A 0.035 INCH GUIDEWIRE WAS INSERTED THROUGH THE TIP BUT DID NOT EXIT THE GUIDEWIRE ACCESS PORT DUE TO THE KINK IN THE SHAFT. WHEN THE SHAFT WAS STRAIGHTENED THE GUIDEWIRE DID EXIT THE GUIDEWIRE ACCESS PORT WITHOUT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE INVESTIGATION CONCLUDED THAT THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF STENT PREMATURELY DEPLOYED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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 BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE GUIDEWIRE THROUGH THE STENT. THE GUIDEWIRE WAS STUCK AT THE GUIDEWIRE EXIT HOLE AND COULD NOT ADVANCE OUT. THE WALLFLEX BILIARY STENT AND GUIDEWIRE WERE REMOVED FROM THE PATIENT. THE PHYSICIAN THEN MANEUVERED THE GUIDEWIRE AND CATHETER TO TRY AND GET THE GUIDEWIRE THROUGH AND AT THIS TIME THE STENT DEPLOYED (UNINTENTIONALLY) FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT DEVICE AND THE SAME GUIDEWIRE. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE GUIDEWIRE THROUGH THE STENT. THE GUIDEWIRE WAS STUCK AT THE GUIDEWIRE EXIT HOLE AND COULD NOT ADVANCE OUT. THE WALLFLEX BILIARY STENT AND GUIDEWIRE WERE REMOVED FROM THE PATIENT. THE PHYSICIAN THEN MANEUVERED THE GUIDEWIRE AND CATHETER TO TRY AND GET THE GUIDEWIRE THROUGH AND AT THIS TIME THE STENT DEPLOYED (UNINTENTIONALLY) FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT DEVICE AND THE SAME GUIDEWIRE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192980 WALLFLEX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570610 0015771586

    Patients

    Seq Age Sex Outcome Treatment
    1