BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX? BILIARY

    MDR report key: 3813059 · Received May 15, 2014

    Report

    Report Number
    3005099803-2014-01995
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE PROXIMAL END OF THE STENT WAS PARTIALLY DEPLOYED BY 60 MM. THE SHAFT WAS KINKED AT 35MM DISTAL TO THE BLUE SECTION OF THE EXTERIOR TUBE AND THE CLEAR SECTION OF THE OUTER SHEATH WAS ACCORDIONED FOR A LENGTH OF 36MM PROXIMAL TO THE INNER MEMBER JACKET. IT WAS CONFIRMED THAT THE STENT WAS NOT DEPLOYED PAST THE POINT OF NO RETURN MARKER BAND. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. DURING ANALYSIS WHEN AN ATTEMPT WAS MADE TO RECONSTRAIN THE STENT, THE EXTERIOR TUBE ACCORDIONED FURTHER AND THE STENT COULD NOT BE RECONSTRAINED. IT WAS POSSIBLE TO FURTHER DEPLOY THE STENT BUT THE STENT WAS NOT FULLY DEPLOYED DURING ANALYSIS. THE EXTERIOR TUBE WAS CUT AT THE DISTAL HANDLE AND THE INNER AND STENT WERE WITHDRAWN FROM THE EXTERIOR TUBE. EXAMINATION OF THE INNER FOUND A SLIGHT TWIST AT THE SKIVE LOCATION, NO OTHER DAMAGE OR KINKS WERE NOTED. NO ISSUES WERE NOTED WITH THE PROFILE OF THE STENT. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, THIS INVESTIGATION IS ASSIGNED THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    CORRECT UPN IS M00576790. NOTE, THIS DEVICE IS NOT SOLD IN USA, BUT IS SIMILAR TO WALLFLEX BILIARY STENT THAT IS SOLD IN USA. REPORTED EVENT OF STENT PARTIALLY DEPLOYED. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS USED DURING A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS NOT ABLE TO FULLY RECONSTRAIN THE STENT AND IT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT CONSEQUENCES AT THE CONCLUSION OF THE PROCEDURE. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS USED DURING A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS NOT ABLE TO FULLY RECONSTRAIN THE STENT AND IT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT CONSEQUENCES AT THE CONCLUSION OF THE PROCEDURE. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290410 WALLFLEX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00576790 16639579

    Patients

    Seq Age Sex Outcome Treatment
    1