BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX? BILIARY

    MDR report key: 3901807 · Received June 30, 2014

    Report

    Report Number
    3005099803-2014-02384
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF STENT DEPLOYED PREMATURELY. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: DEVICE ANALYSIS DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A DEPLOYED WALLFLEX BILIARY STENT AND DELIVERY SYSTEM WERE RECEIVED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE DISTAL HANDLE HAD BEEN RETRACTED PAST THE LIMIT MARKER. NO ISSUES WERE IDENTIFIED WITH THE PROFILE OF THE STENT OR THE CATHETER. GIVEN THE EVENT DESCRIPTION AND THE CONDITION OF THE RETURNED DEVICE, A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 10X40 WALLFLEX FULLY COVERED BILIARY STENT RMV WAS INTENDED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, THE PHYSICIAN FOUND THAT THE STENT WAS ALREADY DEPLOYED IN THE PACKAGE. THE STENT WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 10X40 WALLFLEX FULLY COVERED BILIARY 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. REPORTING WAS REQUIRED BECAUSE THE DEVICE IS ONLY SOLD OUS BUT IS SIMILAR TO THE (B)(4) THAT IS SOLD IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 10X40 WALLFLEX FULLY COVERED BILIARY STENT RMV WAS INTENDED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, THE PHYSICIAN FOUND THAT THE STENT WAS ALREADY DEPLOYED IN THE PACKAGE. THE STENT WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 10X40 WALLFLEX FULLY COVERED BILIARY 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. REPORTING WAS REQUIRED BECAUSE THE DEVICE IS ONLY SOLD OUS BUT IS SIMILAR TO THE (B)(4) THAT IS SOLD IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380185 WALLFLEX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570470 0016586154

    Patients

    Seq Age Sex Outcome Treatment
    1