BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010

    MDR report key: 1913895 · Received December 3, 2010

    Report

    Report Number
    3005099803-2010-05018
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - REPORTED ISSUE OF DEVICE DEPLOYER (HANDLE) BREAK. 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED. THE OUTER SHEATH WAS RETRACTED FROM THE DISTAL TIP BY APPROXIMATELY 1 MM. THE CLEAR OUTER SHEATH WAS KINKED AT VARIOUS LOCATIONS ALONG THE LENGTH OF THE CLEAR OUTER SHEATH. THE BLUE OUTER SHEATH WAS KINKED, STRETCHED AND ACCORDIONED FOR A DISTANCE OF 5 MM AT APPROXIMATELY 30 MM DISTAL TO THE PROXIMAL END OF THE BLUE OUTER SHEATH. THE DISTAL HANDLE WAS DETACHED FROM THE OUTER SHEATH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE SHAFT. THE STAINLESS STEEL SHAFT WAS KINKED AT VARIOUS LOCATIONS ALONG THE LENGTH OF THE SHAFT. DURING ANALYSIS IT WAS NOT POSSIBLE TO RETRACT THE OUTER SHEATH BY HAND SO THE SHAFT WAS DISSECTED PROXIMAL TO THE STENT AND THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. THE OUTER SHEATH WAS UNABLE TO BE MOVED PROXIMALLY OR DISTALLY DUE TO THE KINKS IN THE STAINLESS STEEL SHAFT. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT OR THE INNER LUMEN. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUES IS OPERATIONAL CONTEXT. 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 WALLFLEX ENTERAL DUODENAL STENT WAS USED DURING A DUODENAL STENTING PROCEDURE WITHIN A PATIENT WITH STOMACH CANCER ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A SEVEN CENTIMETER LESION BETWEEN THE STOMACH AND DUODENUM. DURING THE PROCEDURE, THE STENT DEVICE WAS SUCCESSFULLY INSERTED INTO THE ENDOSCOPE WITHOUT RESISTANCE. DURING DEPLOYMENT, AS THE PHYSICIAN WITHDREW THE DEPLOYMENT HANDLE, THE HANDLE DETACHED. AS A RESULT, THE STENT WAS UNABLE TO BE DEPLOYED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A 22 X 90 MM WALLFLEX ENTERAL DUODENAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS USED DURING A DUODENAL STENTING PROCEDURE WITHIN A PATIENT WITH STOMACH CANCER ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A SEVEN CENTIMETER LESION BETWEEN THE STOMACH AND DUODENUM. DURING THE PROCEDURE, THE STENT DEVICE WAS SUCCESSFULLY INSERTED INTO THE ENDOSCOPE WITHOUT RESISTANCE. DURING DEPLOYMENT, AS THE PHYSICIAN WITHDREW THE DEPLOYMENT HANDLE, THE HANDLE DETACHED. AS A RESULT, THE STENT WAS UNABLE TO BE DEPLOYED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A 22 X 90 MM WALLFLEX ENTERAL DUODENAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010 STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565030

    Patients

    Seq Age Sex Outcome Treatment
    1 SCOPE:CF-260H(OLYMPUS)| GUIDEWIRE:HYDRAJAGWIRE